Global Facilities Quality Senior Program Manager

Description

As a Global Facilities Quality Senior Program Manager, you will work closely with all the major functional organizations within Global Facilities, & with the world-wide site Facilities, Global Quality and other major corporate organizations to drive Quality systems projects/programs from initiation to completion. These projects/programs are critical to the success of Facilities and the overall network.

Your responsibilities will include, but are not limited to, the following:

• Collaborate with Global & Site Facilities team to proactively manage projects/programs, such as Management of Change (MOC), Failure Mode and Effect Analysis (FMEA), Calibration, Effective Problem Solving (EPS), Global Deviation Management System (GDMS), Risk-Based Thinking (RBT) Risk & Opportunity (R&O) depository, etc. to enhance “Manage Facilities” Quality Management System (QMS) Business Process (BP).
• Creating, leading, driving & maintaining Projects/Programs, including project definition, work breakdown structures, schedules, communication plans, scope documents, and stakeholder analysis; organizing and coordinating project meetings; developing meeting presentations, agendas, minutes, tracking and following up on action items and early identification and resolution of project risks, establishing of metrics, training, software and measuring and monitoring of program status.
• Supporting the Global Facilities Quality Core Team meetings to drive alignment and continuous improvement to support Manage Facilities QMS BP. This includes:Creating and monitoring metrics to measure, monitor and drive continuous improvement of the BP.
  Maintenance of Central Governance repository platform to support Manage Facilities QMS process and all Quality roadmap
  Implementation of critical new business processes that support continuous manufacturing improvement
  Participating and leading Business Process improvement projects on Reliability and Cost projects/programs which contributes directly to Effectiveness & Efficiency KPIs. This includes the implementation of project management within Facilities organization.
  Managing external audits including setup, coordination and successful follow up with the Global Facilities organization. This includes the identification and implementation of QMS processes and tools to enable continued success with customers.
  Enhancing and driving a proactive process based on internal audit program and tracking and supporting any NC follow up through close out. And incorporating lessons learned to continually improve the QMO business processes.
  Managing the communications and access to information from the QMS program and projects through various tools and approaches such as SharePoint web pages, reports and other means
  
• Supporting Global Fac Work-Force Development (WFD) to establish and maintain Global Fac training plans, training assignment, Training Needs Analysis (TNA), establishing to Learning Items, quizzes, and tracking of assigned training status across Global Fac network. Supporting Global Fac Documentation to maintain Global Fac Controlled Document Library, including enforcing documentation control, publishing of ECNs notifications, & conducting Periodic Document Review (PDR).

Qualifications

The successful candidate for this position will have:

• Excellent skills for leading or facilitating multi-organizational teams to success on complex multidimensional projects/programs
• Excellent communication skills to build teams comprised of key skills, to drive progress to plan and to get management support and buy-in for complex projects/programs
• Ability to develop and maintain positive, cooperative, team-oriented relationships with peers, coworkers, management, customers, and auditors
• 2 or more years of Facilities Semiconductor industry engineering experience
• Skills in the creation and management of projects/programs (TABLEAU reports, Sharepoint Online (SPMO), etc)
• Working knowledge and drive quality programs such as MOC, FMEA, Calibration, GDMS, Error-Proofing, etc

Senior Quality Management Systems EngineerEducation

• Bachelor’s degree in engineering or equivalent
• Project/Program management experiences are preferable
• ISO or IATF Audit experience including training and certification are preferable

Workplace

• Travel Required : Yes – Domestic and International travel as required by business needs
• Environment : Office
• Shift : Normal shift (8+ hour)
• GJS : E2 to E3, or P2 to P3

Leads people who are responsible for internal business projects and programs involving department or cross-functional teams of subject matter experts, delivering products through the design process to completion. Plans and directs schedules as well as project budgets. Monitors the project from inception through delivery. May engage and oversee the work of external vendors. Assigns, directs and monitors system analysis and program staff. These positions' primary focus is project/program management, rather than the application of expertise in a specialized functional field of knowledge although they may have technical team members.

To ensures that all supply chain processes, meet stringent quality standards. This role involves close collaboration with suppliers, logistics, and internal teams to maintain consistency, reduce risks, and enhance customer satisfaction by upholding product and process quality.

1. Assists develop and setup a standardize FSMS (HACCP as based) that meet the legal and regulation compliance demand across various national and international legal frameworks.

2. Assist Setup food safety internal audit system to verify the effectives of the FSMS implementation.

3. Assist manage variation in the food safety of compliance system in local sites due to resource and culturally different.

4. Assist setup supplier food safety control system and supplier food safety audit system.

5. Develop and provide training for food safety and quality requirements.

6. Develop and maintain documentation such as SOP’s, as well as maintenance of manuals, policies and procedures as relate to any food safety concerns.

7. Update existing food safety procedures and documentation to keep up with changing requirements.

8. Oversee proper maintenance and sanitation of all facility to comply with food safety requirements.

9. Ensure that all company food safety and quality assurance procedures are followed and documented correctly at all times.

10. Plan, Arrange a monitor outlet food product microbial test result and trend analysis.

11. Be the main contact point with SFA (Singapore Food Agency).

12. Conduct facility food safety audits as well as manage third party audits e.g SS444:2018 / ISO 22000

13. Assist on provide Food Safety consultancy and food safety audit for PUTIEN sister company / Partner / Franchisee.

14. Assists prepare periodical FSMS implement progression and outcome report and review the effectiveness’ of the FSMS implementation.

15. Work closely with operation team on provide technical assistant and guidance in conducting food safety related investigation on customer feedback and nonconformance issues and give recommendation for continual improvement.

16. Conduct routine inspection for products processed at production.

17. Assists and involve in 3rd party food safety audit or inspection.

18. Provide assistant in any ad hoc assignment if any

Qualifications:

• Diploma / Degree (Preferably in Food Science, Food Technology)
• Familiar with Word, Excel, and PowerPoint.
• Good written and verbal communication skills.
• At least 1 year experience as QA / QC
• Relevant experience in food manufacturing sector will be an added advantage
• Positive working attitude with good adaptability
• Strong eyes for details
• Strong analytical and problem-solving skills
• Bilingual in both spoken and written English
• Computer literacy
• Willing to take initiatives
• Comprehensive knowledge of HACCP, GMP’s, and GHP’s.

Working location at Senoko South Road

Quality Assurance Manager

Job Responsibilities:

Quality Assurance

· Establishment, Maintenance and Continuous Improvement of Company’s Quality Management System (QMS), Class Approvals (Marine) and Regulatory Requirements (Part 145).

· Plan, organise and take lead to drive Quality initiatives and promote quality culture within the company.

· Maintaining and continually improving quality performance, to meet the maintained or all Divisions.

· Perform all essential audits and inspecting internally and/or by third party or client as and when required.

· Establishment, implementation and co-ordination of the audit & approval program, reporting of audit outcomes and ensuring follow up of corrective actions.

· Assist department to follow up on root cause analysis and creation of appropriate action plan to prevent recurrence of issues, by providing training and guidance to the team whenever required.

· Conduct incident investigation and prepare concise investigation reports with in accordance to the regulatory requirement.

· Training and development of employees with respect to QMS and its related processes, quality principles, tools and techniques etc.

· Ensure all licensing at Singapore site and products/services are managed for new applications and renewals.

· Budget allocation and control of costs for QMS related projects; resource management; training; third party audit and Certification costs; and professional subscription costs.

• Effectively implements quality procedures for all allocated sites, in line with legislation, regulatory and guidelines. Documents and maintains the register of quality approvals, procedures and accreditations for allocated sites / geographies.

• Communicates to all allocated sites quality procedures, ensuring all relevant regional colleagues are aware of their responsibilities in supporting / upholding Quality Assurance processes.

• Manages operational, technical, health, safety and environmental audits in line with the audit calendar

• Participates in quality, non-conformance and complaint investigations, ensuring findings are documented, reported and escalated appropriately. Monitors and follows up on supplier CAPA and improvement actions

• Contributes to statistical analyses on which to base recommendations for improvement

• Advises business leaders and senior managers of compliance issues or matters requiring supplier quality development or improvement

• Any ad-hoc duties or projects as assigned.

Skills

• Makes sense of complex, high quantity, and sometimes contradictory information to effectively solve problems

• Gains the confidence and trust of others through honesty, integrity, and authenticity

• Develops and delivers multi-mode communications that convey a clear understanding of the unique needs of different audiences

• Knows the most effective and efficient processes to get things done, with a focus on continuous improvement

• Anticipates and balances the needs of multiple stakeholders

• Uses compelling arguments to gain the support and commitment of others

• Interprets and applies key financial indicators to make better business decisions.

• Plans and prioritises work to meet commitments aligned with goals.

• Operates effectively, even when things are not certain, or the way forward is not clear

• Knows the most effective and efficient processes to get things done, with a focus on continuous improvement

• Builds partnerships and works collaboratively with others to meet shared objectives

Job Requirements:

· Degree in Engineering or Quality Assurance or equivalent with at least 5 years of relevant managerial experience in marine, aviation or related Industry.

· Certified ISO9001:2015 internal/lead auditor qualification.

· Successful completion of the CAAS M10/L11/L12 Examination.

· Able to interpret CMM, in particular IPL (illustrated part listing) and special equipment and tooling listing will have added advantage.

· Preferably have experience in liaising with OEM for capability expansion.

· Certification or experience in Lean, Kaizen and 5S or familiar with common quality tools and techniques.

· Knowledge of relevant standards, and the ability to become conversant with the rules and regulations relating to the quality systems specific to the marine, defence and aviation industries;

· Experience in practical administration, maintenance and development of Quality Management Systems.

· Knowledge of the practical implementation and development of Continuous Improvement and Lean or other similar methodology in a manufacturing, engineering and/or supply chain environment.

· Good leadership and proven managerial skills to be able to lead and motivate the team.

· Meticulous, resourceful, team player and possess strong organization skills.

· Internet savvy and proficient in MS Office applications (ie. Outlook, Excel, Words and Powerpoint etc)

· Effective oral and written communication and interpersonal skills.

· The ability to plan and prioritize work and work under high pressure to tight deadlines yet flexible and adaptable to changing needs and situations.

Position Summary:

The Quality Control Engineer is an experienced engineer with a good understanding of construction principles, standards and processes. The QC Engineer is responsible to identify the measures and controls required to give a reasonably practical assurance that the quality of the works will be achieved.

The QC Engineer will have a detailed understanding of the project specifications and legal/contract/company quality requirements.

This QC Engineer will be involved in reviewing method statements and preparing inspection and test plans. They will also train and advise project staff on quality matters, monitor the progress of submissions, inspections and tests. They will coordinate the management of defects and nonconformances.

Note: The QC Engineer does is not responsible to undertake frontline inspections or tests, they are there to support the Site Engineers and ensure the Quality Control systems is functioning effectively.

Responsibilities:

•Study and understand legal and contractual requirements for the works including specification

•Study and understand standards and in-house requirements

•Develop inspection & test plans and records systems, and work procedures

•Review method statements, and confirm they are being followed

•Train and advise project personnel on the QC system;

•Monitor the QC activities of site engineers/supervisors, and review quality records

•Report on the QC status of the works, maintain QC filing, make QC submissions to Client

•Coordinate the reporting and resolution of non-conforming works

Skill:

•Excellent technical knowledge of construction methods, quality controls, risks to quality and acceptance criteria

•Well organised/effective administrator

•Able to work in a team and communicate effectively while also being strongly independent and able to challenge non-compliance.

•Computer literate / digital tool literate

Requirement :

Singaporean only

University Degree in Civil or Structural Engineering (or equivalent)

Engineer: 4 years + experience in on-site construction works

The Quality Engineer applies engineering principles and techniques to meet the quality targets and organisational objectives in a manufacturing environment. He/She also assists in analysing manufacturing and quality issues make recommendations for out of control processes.

In addition, the Quality Engineer participates in quality improvement projects in accordance with organisational objectives.

The Quality Engineer is required to have strong communication skills, good teamwork and an analytical mind to perform his/her role well to achieve the desired organisational outcomes.

~ Assist in implementation of improvement projects.
~ Attend to internal or external audits related issues.
~ Collect data for analysis.
~ Enforce practices of good safety culture and good manufacturing practices.
~ Ensure adherence to processes and procedures.
~ Ensure all quality plans are properly documented and maintained.
~ Ensure no expired tools running in the production line.
~ Facilitate the implementation of quality system in the organisation.
~ Identify opportunity for continuous improvement projects.
~ Implement calibration cost reduction activities.
~ Interpret information provided by the network/dashboard for quality performance monitoring.
~ Maintain production yield targets.
~ Monitoring quality control and assurance processes.
~ Perform evaluation/experiments.
~ Supervise manufacturing work for workplace safety and health compliance.

As the Equipment Supplier Quality Principal Engineer, you will lead a global team to ensure the highest quality standards for equipment supplied to our company. You will be responsible for establishing and maintaining strong relationships with critical suppliers, managing supplier quality governance processes, and driving continuous improvement programs. This role requires collaboration with various departments, including development, engineering, manufacturing, and procurement, to meet the business needs and ensure supplier compliance with quality management systems.

Key Responsibilities:

• Lead and manage a global team of Supplier Quality Engineers to achieve best-in-class supplier quality performance.
• Establish and maintain close relationships with critical suppliers' management teams and internal stakeholders.
• Ensure consistent management and deployment of quality requirements and supplier quality governance processes.
• Drive continuous improvement programs with critical suppliers to enhance quality performance.
• Ensure suppliers deliver the highest possible quality materials and comply with Quality Management System (QMS) requirements, standards, and other quality safeguard programs.
• Conduct regular audits and assessments of supplier processes and quality systems.
• Develop and implement supplier quality metrics and performance monitoring systems.
• Collaborate with development, engineering, manufacturing, and procurement teams to resolve quality issues and implement corrective actions.
• Provide training and support to suppliers on quality standards and requirements.

Qualifications:

• Bachelor's degree in Materials Science, Electrical Engineering, Mechanical Engineering, or a related field.
• Minimum of 8-10 years of experience in supplier quality management, preferably in the semiconductor or electronics industry.
• Strong knowledge of quality management systems, standards, and methodologies.
• Proven experience in leading and managing a global team.
• Excellent communication and interpersonal skills.
• Strong analytical and problem-solving abilities.
• Ability to work effectively in a fast-paced and dynamic environment.

Preferred Qualifications:

• Master's degree in a related field.
• Certification in quality management (e.g., Six Sigma, ISO 9001).
• Experience with supplier quality management in a multinational corporation.

As a Wet Chemical and Specialty Chemical Global Supplier Quality Engineer, you will be responsible to support the overall metrological alignment strategy, execution plans and excursion prevention programs to develop Suppliers through Continuous Improvement Programs to ensure advance metrology is constantly applied to materials procured materials/services to Micron. You will work in close partnership with key stakeholders such as Global Quality, Global Procurement, Global Manufacturing Central Team (MCT), Operations, Product Engineering and R&D to develop, execute and measure the effectiveness of Supplier Programs.

In addition, you will support Supplier Performance Reviews to ensure suppliers receive timely and accurate supplier performance feedback based on consistent metrics and that the expectation of continuous improvement is understood and realized. The position will be reporting to Principal Lead, Front End Supplier Engineer.

Role Responsibility and Tasks

1. Development Phase - Sourcing, Selection and Qualification Phase

• Drive Wet Chemical and Specialty Chemical Quality risk assessment and ensure all risks are mitigated to support Fabs qualification activities.
• Participate, support, and recommend from quality perspective on global sourcing and segmentation strategies, including business continuity, benchmarking, new markets, request for quotation (RFQ)/ request for information (RFI), sourcing, selection, cost savings and other analytics.
• Lead technical risk assessment audit for new supplier/ material engagement or qualification to assess their capability and readiness for High Volume Manufacturing (HVM).
• Set up, communicate, and ensure suppliers understood and comply with Micron Supplier Requirements Standards (SRS).
• Support cross fab technology transfer activities in terms of new technology Bill of Materials (BOM) and driving global specifications alignment.
• Collaborate with Suppliers on their outgoing analysis capability to align Best-In-Class (BIC) method detection.
• Align and guide Suppliers to aligned Fab’s advance technology needs which include but not limited to:Study BIC test analysis method and align with Supplier with the collaboration with site Chem Lab to support manufacturing needs (FOAK eval, routine quality monitoring, troubleshooting, improvements, etc.).
  Align, correlate, document with suppliers on lab methods / tools / practices and target to achieve low detection at ppq level contamination.
  To provide a platform for technical or knowledge sharing for SQE team.
  Conduct Regular Technical Meetings with Suppliers on metrology CIPs.
  Conduct constant look out of advance chemical analytical equipment and technology, work with internal site/supplier on results correlation and deploy into CIP with suppliers in compliance to advance technology
  Conduct research for ≤ 10nm particle detection and work with internal site/supplier on results correlation, and deploy into CIPs with suppliers in compliance to advance technology
  Lead Suppliers towards ISO17025 compliance.
  
• Set up, communicate, and ensure suppliers understood Micron metrology expectations.
• Support Category Strategy for Benchmark to/with Suppliers to ensure Controls and Preventive measures are in place to support Shift-Left-Strategy. Supplier/Material development programs.
• Participate and support test method benchmarking and analytics with Suppliers

2. HVM Phase - Supplier Development and Excursion Management

• Lead Wet Chemical and Specialty Chemical Global Material Specification definition and alignment activities with internal stakeholders and suppliers.
• Deploy Wet Chemical and Specialty Chemical category Quality programs, lessons learnt and benchmark to/ with suppliers to ensure controls and preventive measures are in place to support Shift-Left-Strategy.
• Host regular Quality and Technical Review (QTR) meetings with strategic and developing suppliers.
• Manage supplier and sub-supplier changes in Supplier Change Management (SCM).
• Work collaboratively with Global OCT MTE, Operations and Facility globally for deep dive root cause investigations, corrective and preventive actions to ensure no recurrence of related Quality issues.
• Define, manage, and monitor supplier monthly quality performance metrics and their compliance to Micron SRS.
• Enhance the supplier quality business processes to improve productivity and efficiency.
• Support Global Procurement on supplier performance rating on Quality related criteria.
• Lead and conduct supplier audit.

Required:

Bachelor's Degree on engineering or related field.

Desired:

Master's Degree on engineering or related field.

Experiences:

• Previous experience working in Chem lab, wet chemical and specialty chemical under semiconductor industry field is preferred
• Basic Knowledge of ISO9001, IATF16949 & ISO17025 requirements.
• Basic knowledge of Wet Chemical and Specialty Chemical applications and wafer manufacturing process.
• Strong analytical skills with experience in MSA and calibration, statistical methods, FMEA, problem solving methodology and quality management systems.
• Ability to interact effectively with internal and external interested parties, across all levels.
• Ability to collaborate effectively with cross-functional organizations to understand needs and translate them into actionable plans, deliverables, and resource requirements.

Qualification:

• Minimum of 5 years’ in semiconductor field.

Develops, evaluates, revises, and applies technical quality assurance protocols/methods to inspect and test in-process raw materials, production equipment, and finished products. Ensures activities and items are in compliance with both company quality assurance standards and applicable government regulations. Performs analysis and identifies trends in the inspection of finished products, in-process materials and bulk raw materials, and recommends corrective actions when necessary. Ensures that established manufacturing inspection, sampling and statistical process control procedures are followed. May assure compliance to in-house and/or external specifications and standards, such as GMPs and ISO regulations. Evaluates and analyzes the efforts in organizing, documenting, and interpreting inspection support documents and records.

Responsibilities:

• To operate CNC milling and turning (3 axis & 5 axis)
• Able to scheduling machined parts to customers in time
• General duties

Requirements:

• Minimum Diploma in Mechanical Engineering or Degree in Mechanical Engineering
• At least 5 years of working experience
• Ability to multi-task and possessed initiative
• Able to start work immediately

Friendly working environment

Company Details:

SUPERFIX (SINGAPORE) PTE LTD

5, Yishun Industrial Street 1,

North Spring Bizhub, #07-08,

Singapore 768161

Tel: 6748 2122

Fax: 6747 9838

Interested applicants, please email your resume to [email protected]

Job description

Position Overview: We are seeking an experienced Pest Control Supervisor to join our team. The ideal candidate will possess extensive knowledge of pest control methods, excellent problem-solving skills, and a passion for delivering exceptional service.

Key Responsibilities:

• Supervise and train pest control technicians in safe and effective pest management practices.
• Conduct thorough inspections and assessments to identify pest issues and recommend appropriate treatments.
• Develop and implement pest control plans tailored to client needs.
• Address client inquiries and resolve any issues that arise promptly.
• Stay updated on industry trends, pests, and treatment methods.

Qualifications:

• Proven experience in pest control, with a minimum of [2 years] in a supervisory role.
• Strong knowledge of pest biology, behavior, and control methods.
• Excellent problem-solving and decision-making skills.
• Effective communication and interpersonal skills.
• Valid pest control certification/license as required.
• Ability to lead a team and foster a positive work environment.

What We Offer:

• Opportunities for professional development and training.
• A supportive and dynamic work environment.

How to Apply: If you are passionate about pest control and have the leadership skills to make a difference, we want to hear from you! Please submit your resume or call 9007 4056.

JOB DESCRIPTION:

Department: MLCC production

Reports to: Manager

Functional relationships:

- MLCC production control in Japan headquarter & factories

- MLCC production control in oversea affiliates: China & ASEAN

POSITION PROFILE:

This position works closely with global affiliates, especially Japan counterparts, to develop and improve production control systems for higher productivity, accurate forecast, and on-time delivery. Recommend changes to current practices and works with business representatives to define requirements and propose appropriate solutions. Display a high level of organizational awareness and leadership skills by working in a collaborative manner with other departments within the organization.

Key Duties & Responsibilities:

• Act as an expert of Production Control and guide for specialized subjects.
• Understand the language/terms/jargon in production control expertise.
• Act as the “go to” person within a department for questions and problems.
• Explain expertise clearly and give advice.
• Promote Innovation in the Organization.
• Help to improve the business performance by identifying the problematic areas and proposing relevant technical solutions.
• Work with business representatives to define requirements and design appropriate solutions.
• Align operation change with related parties and follow up system development & implementation schedule.
• Measure effectiveness and introduce new system & operation clearly to others.
• Be a bridge to connect with Japan headquarter planning and production control in horizontal deployment as well as seeking partnership in new development projects.
• Provide training and coaching to develop individual knowledge and skill for production control.

Ability/Competency required:

• To hold bachelor’s degree or master’s degree in any fields.
• To have more than 4 years working experience in electronics manufacturing industry.
• Deep & specialized knowledge in production control.
• Fluent in Japanese language.
• Logical thinking, analytical skill, and good business sense.
• Strong mind-set for change and improvement.
• Proactive attitude and strong communication and interpersonal skills.
• Networking ability with business counterparts.

Responsibilities:

• Online Quality Checking (Metal Detector, Cooker, Pasteurizer, Steamer)
• Online Finished Product Testing
• Monthly Verification of CCP (Critical Control Point)
• Online Verification Sampling for Microbial Analysis
• Internal Calibration of Weighing Scales
• Verification on goods return
• Handle Customers’ Complaint
• Conduct routine physical, chemical, sensory and other analyses accordingly.
• Take appropriate decisions for rework of material based on historical trend and in consultation with seniors
• Raise non-conformation for quality deviations of Raw Material/Finished Goods and follow up with proper closure of corrective and preventive action
• Initiate actions to investigate customer complaint in consultation with relevant team members
• Collect comprehensive evidence/crucial data, provide sound reasoning and propose possible root cause for customer complaints and internal rejection
• Maintain up-to-date quality control programs, policies, process workflows, procedures and work instructions

REQUIREMENTS:

• Diploma / Degree in Food Science preferred
• At least 2 years of relevant experience will be considered for Senior position
• Experienced and passionate in Continuous Improvement
• Exceptional problem-solving skills
• Good Knowledge of Quality Management Systems (HACCP, BRC, ISO 22000)
• Good Communication, Organizational and Analytical Skills
• Strong ability to work well in a team and independently
• Excellent IT skills, particularly in MS Excel, PowerPoint, Word, Access
• Ability to work with multiple priorities in a fast-paced environment is required.
• 5 Days Work Week + 1 Sat ( Mon-Fri 1230-10pm, Sat 9am-630pm) or 5 Days Work Week + 1 Sat ( Mon-Fri 9am-630pm, Sat 9am-630pm)
• Undertake any other ad-hoc projects/ tasks assigned
• Job Scope, Work Day and Work Hours subject to changes depending on work requirement
• Fresh grads are welcome
• Salary package commensurate with experience

Essential Duties and Responsibilities:

1. Quality Assurance and Control:

• Develop, implement, and maintain quality assurance plans, procedures, and control measures.
• Monitor and analyse production processes to detect and resolve quality issues.
• Ensure compliance with relevant regulatory requirements, including FDA, ISO 13485, and other applicable standards.
• Support internal and external audits and regulatory inspections.
• Investigate and resolve product-related issues, deviations, and non-conformities, with the authority to recommend corrective and preventive actions.
• Ensure the non-conformance or quality issue is resolved and complete in a timely manner.
• Participate in new product introductions to ensure quality is built into all products early in their life cycle
• Support validation processes including IQ, OQ, PQ, process validation and test method validation.

2. Process Improvement

• Identify opportunities for process improvements to enhance product quality and manufacturing efficiency.
• Lead and drive QA initiatives across the product areas
• Lead or participate in root cause analysis and corrective action planning.
• Support and drive cost improvement project

3. Customer Interaction:

• Address customer complaints and feedback related to product quality.
• Work closely with customers to understand their quality requirements and ensure that products meet their specifications.
• Communicated on any potential change request of the processes to customer.
• Provide technical support and quality-related information to customers.

4. Documentation and Reporting:

• Maintain comprehensive records of quality control activities, inspection results, and non-conformance reports.
• Prepare and support monthly / annual quality reports to management and other stakeholders.
• Ensure proper documentation and traceability throughout the manufacturing process.

5. Training and Development:

• Train manufacturing staff on quality standards, procedures, and best practices.
• Promote a culture of quality and continuous improvement within the organization.

Education/Experience and Qualifications:

• Degree in Engineering or science, with 2 - 5 years of progressive Quality responsibility, preferably in medical device / pharmaceutical manufacturing.
• Diploma holders in Engineering or science with more than 5 years' experience in Quality are welcomed to apply
• Knowledge of regulatory requirements and quality standards, including FDA regulations and ISO 13485 standards.
• Strong analytical and problem-solving skills, with the ability to troubleshoot complex issues.

We are representing an MNC in the Aviation and Marine Equipment industry to hire for a Quality Assurance Manager.

Responsibilities:

• Oversee and improve the QMS to meet regulatory and audit requirements.
• Lead quality initiatives, promoting best practices across the organization.
• Perform internal and external audits, ensuring corrective actions are implemented.
• Train employees on quality systems and processes.
• Manage budgets for quality-related projects and certifications.
• Conduct incident investigations and ensure proper reporting.
• Ensure compliance with licensing and regulatory standards at key locations.
• Collaborate with teams to address non-conformance issues and follow up on supplier actions.

Skills & Requirements:

• Certified in ISO9001/ AS9100 / AS9110 with strong auditing skills.
• Familiarity with Aerospace Part 145 Requirement
• Has passed the CAAS Air Legislation examination paper M10, L11, L12
• Knowledge of industry standards and quality improvement tools (Lean, Kaizen, 5S).

Interested candidates please apply here.

EA Personnel (Koh Pei Wen)

EA Reg: R23115205

APBA TG Human Resources Pte Ltd

EA License: 14C7275

Essential Duties and Responsibilities:

1. Quality Assurance and Control:

• Develop, implement, and maintain quality assurance plans, procedures, and control measures.
• Monitor and analyse production processes to detect and resolve quality issues.
• Ensure compliance with relevant regulatory requirements, including FDA, ISO 13485, and other applicable standards.
• Support internal and external audits and regulatory inspections.
• Investigate and resolve product-related issues, deviations, and non-conformities, with the authority to recommend corrective and preventive actions.
• Ensure the non-conformance or quality issue is resolved and complete in a timely manner.
• Participate in new product introductions to ensure quality is built into all products early in their life cycle
• Support validation processes including IQ, OQ, PQ, process validation and test method validation.

2. Process Improvement

• Identify opportunities for process improvements to enhance product quality and manufacturing efficiency.
• Lead and drive QA initiatives across the product areas
• Lead or participate in root cause analysis and corrective action planning.
• Support and drive cost improvement project

3. Customer Interaction:

• Address customer complaints and feedback related to product quality.
• Work closely with customers to understand their quality requirements and ensure that products meet their specifications.
• Communicated on any potential change request of the processes to customer.
• Provide technical support and quality-related information to customers.

4. Documentation and Reporting:

• Maintain comprehensive records of quality control activities, inspection results, and non-conformance reports.
• Prepare and support monthly / annual quality reports to management and other stakeholders.
• Ensure proper documentation and traceability throughout the manufacturing process.

5. Training and Development:

• Train manufacturing staff on quality standards, procedures, and best practices.
• Promote a culture of quality and continuous improvement within the organization.

Education/Experience and Qualifications:

• Degree in Engineering or science, with 2 - 5 years of progressive Quality responsibility, preferably in medical device / pharmaceutical manufacturing.
• Diploma holders in Engineering or science with more than 5 years' experience in Quality are welcomed to apply
• Knowledge of regulatory requirements and quality standards, including FDA regulations and ISO 13485 standards.
• Strong analytical and problem-solving skills, with the ability to troubleshoot complex issues.

Quality Assurance Manager

Job Responsibilities:

Quality Assurance

· Establishment, Maintenance and Continuous Improvement of Company’s Quality Management System (QMS), Class Approvals (Marine) and Regulatory Requirements (Part 145).

· Plan, organise and take lead to drive Quality initiatives and promote quality culture within the company.

· Maintaining and continually improving quality performance, to meet the maintained or all Divisions.

· Perform all essential audits and inspecting internally and/or by third party or client as and when required.

· Establishment, implementation and co-ordination of the audit & approval program, reporting of audit outcomes and ensuring follow up of corrective actions.

· Assist department to follow up on root cause analysis and creation of appropriate action plan to prevent recurrence of issues, by providing training and guidance to the team whenever required.

· Conduct incident investigation and prepare concise investigation reports with in accordance to the regulatory requirement.

· Training and development of employees with respect to QMS and its related processes, quality principles, tools and techniques etc.

· Ensure all licensing at Singapore site and products/services are managed for new applications and renewals.

· Budget allocation and control of costs for QMS related projects; resource management; training; third party audit and Certification costs; and professional subscription costs.

• Effectively implements quality procedures for all allocated sites, in line with legislation, regulatory and guidelines. Documents and maintains the register of quality approvals, procedures and accreditations for allocated sites / geographies.

• Communicates to all allocated sites quality procedures, ensuring all relevant regional colleagues are aware of their responsibilities in supporting / upholding Quality Assurance processes.

• Manages operational, technical, health, safety and environmental audits in line with the audit calendar

• Participates in quality, non-conformance and complaint investigations, ensuring findings are documented, reported and escalated appropriately. Monitors and follows up on supplier CAPA and improvement actions

• Contributes to statistical analyses on which to base recommendations for improvement

• Advises business leaders and senior managers of compliance issues or matters requiring supplier quality development or improvement

• Any ad-hoc duties or projects as assigned.

Skills

• Makes sense of complex, high quantity, and sometimes contradictory information to effectively solve problems

• Gains the confidence and trust of others through honesty, integrity, and authenticity

• Develops and delivers multi-mode communications that convey a clear understanding of the unique needs of different audiences

• Knows the most effective and efficient processes to get things done, with a focus on continuous improvement

• Anticipates and balances the needs of multiple stakeholders

• Uses compelling arguments to gain the support and commitment of others

• Interprets and applies key financial indicators to make better business decisions.

• Plans and prioritises work to meet commitments aligned with goals.

• Operates effectively, even when things are not certain, or the way forward is not clear

• Knows the most effective and efficient processes to get things done, with a focus on continuous improvement

• Builds partnerships and works collaboratively with others to meet shared objectives

Job Requirements:

· Degree in Engineering or Quality Assurance or equivalent with at least 5 years of relevant managerial experience in marine, aviation or related Industry.

· Certified ISO9001:2015 internal/lead auditor qualification.

· Successful completion of the CAAS M10/L11/L12 Examination.

· Able to interpret CMM, in particular IPL (illustrated part listing) and special equipment and tooling listing will have added advantage.

· Preferably have experience in liaising with OEM for capability expansion.

· Certification or experience in Lean, Kaizen and 5S or familiar with common quality tools and techniques.

· Knowledge of relevant standards, and the ability to become conversant with the rules and regulations relating to the quality systems specific to the marine, defence and aviation industries;

· Experience in practical administration, maintenance and development of Quality Management Systems.

· Knowledge of the practical implementation and development of Continuous Improvement and Lean or other similar methodology in a manufacturing, engineering and/or supply chain environment.

· Good leadership and proven managerial skills to be able to lead and motivate the team.

· Meticulous, resourceful, team player and possess strong organization skills.

· Internet savvy and proficient in MS Office applications (ie. Outlook, Excel, Words and Powerpoint etc)

· Effective oral and written communication and interpersonal skills.

· The ability to plan and prioritize work and work under high pressure to tight deadlines yet flexible and adaptable to changing needs and situations.

1. Review and refining existing process flow, and process failure mode and effect analysis (FMEA)
2. Optimizing existing standard operating procedure for quality inspection, cycle time for inspection activities & calibration schedule program.
3. Data trending of quality complains & defect, NC & CAPA through use of SPC.
4. Ad-hoc activities for LHR review and documentation.

JOB DESCRIPTION

Department: Quality Assurance

Report to: Senior Engineer

Functional Relationships with:

Relationship with Production, Process Engineering, Machine Engineering, Quality Control, Sales

POSITION PROFILE:

Based in: Singapore

Job Site: Yishun

The successful candidate will: take charge of customer handling (care/support) scope. Provide statistical information about MLCC customer complaint for quality improvement by identifying the testing methods and samples and provide necessary support to various departments.

Key Duties & Responsibilities:

• Handling of internal complaint from production, sales etc.
• Handling of external complaint from customers
• Analysis the complaint and establish statistical data by identifying sample size and acceptable error
• Monitor and review quarterly data based on customer’s complaint
• Prepares reports by collecting, analyzing and summarizing data
• Provide recommendations for improvement and reduction of complaint
• Provide technical support to the customer
• Manage of detective material return

Ability / Competency Required:

• Degree in any Engineering field
• Good interpersonal and communication skills
• Ability to work well in a team
• Problem solver
• Ability to perform multi-tasking
• Knowledge of IATF16949 will be an added advantage
• With statistical knowledge
• Attention to detail

Job Description

As a Central Quality data analytic engineer, your main responsibility will be as follows:

• working with enormous data and conduct analytics on sophisticated datasets to assist AT to better understand operation. These involve providing solution(s) to pressing manufacturing process issues to drive yield and quality improvement programs particularly on test triggers governance.
• You will identify, collect and engineered both structured and unstructured datasets from separate sources to make available in Big Data platform for user query and analysis. In the process, you may build visualization for business insights and needs.
• You may also build and implement frontier's predictive analytics model, strategy and operation to identify untapped opportunities and expose hidden risk buried inside vast amount of data.
• Develops, evaluates, revises, and applies technical quality assurance protocols/methods to inspect and test in-process raw materials, production equipment, and finished products.
• Ensures activities and items are in compliance with both company quality assurance standards and applicable government regulations.
• Performs analysis and identifies trends in the inspection of finished products, in-process materials and bulk raw materials, and recommends corrective actions.
• Ensures that established manufacturing inspection, sampling and statistical process control procedures are followed.
• May assure compliance to in-house and/or external specifications and standards, such as GMPs and ISO regulations.
• Evaluates and analyzes the efforts in organizing, documenting, and interpreting inspection support documents and records.

Develops, evaluates, revises, and applies technical quality assurance protocols/methods to inspect and test in-process raw materials, production equipment, and finished products. Ensures activities and items are in compliance with both company quality assurance standards and applicable government regulations. Performs analysis and identifies trends in the inspection of finished products, in-process materials and bulk raw materials, and recommends corrective actions when necessary. Ensures that established manufacturing inspection, sampling and statistical process control procedures are followed. May assure compliance to in-house and/or external specifications and standards, such as GMPs and ISO regulations. Evaluates and analyzes the efforts in organizing, documenting, and interpreting inspection support documents and records.

• Oversee the entire ICA design process, from concept to implementation, ensuring project is delivered on
• time, within specifications and meeting industrial standards.
• Lead and mentor a team of ICA engineers and ensuring the quality in design work.
• Oversee the development of control logic, CMS programming, HMI interfaces, and Sub-Control systems, ensuring seamless communication and synchronisation of control components.
• Oversee the selection of instrumentation, sensors, and transmitters for accurate data acquisition, measurement, and feedback control.
• Oversee the configuration and deployment of the Control Monitoring System for seamless process control and integration of subsystems.
• Ensure ICA designs adhere to relevant safety standards (such as SIL, IEC 61511) and cybersecurity protocols to mitigate operational risks.
• Collaborate with process team to optimise the processes through intelligent control strategies, adaptive algorithms, and data-driven insights.
• Coordinate validation activities, including factory acceptance testing (FAT) and site acceptance testing (SAT), to ensure systems meet performance criteria.
• Develop RFQ and collaborate with suppliers and vendors to source components, equipment, and systems required for ICA and ensuring they meet quality and performance standards.
• Oversee testing and commissioning of the CMS, coordinating with process team to ensure system operate as intended.
• Ensure clear and consistent communication with project client and consultant throughout the project, providing updates, addressing concerns and managing expectations.
• Manage ICA design budgets, including cost estimation, resource allocation, and cost control.

As a Wet Chemical and Specialty Chemical Global Supplier Quality Engineer, you will be responsible to support the overall metrological alignment strategy, execution plans and excursion prevention programs to develop Suppliers through Continuous Improvement Programs to ensure advance metrology is constantly applied to materials procured materials/services to Micron. You will work in close partnership with key stakeholders such as Global Quality, Global Procurement, Global Manufacturing Central Team (MCT), Operations, Product Engineering and R&D to develop, execute and measure the effectiveness of Supplier Programs.

In addition, you will support Supplier Performance Reviews to ensure suppliers receive timely and accurate supplier performance feedback based on consistent metrics and that the expectation of continuous improvement is understood and realized. The position will be reporting to Principal Lead, Front End Supplier Engineer.

Role Responsibility and Tasks

1. Development Phase - Sourcing, Selection and Qualification Phase

• Drive Wet Chemical and Specialty Chemical Quality risk assessment and ensure all risks are mitigated to support Fabs qualification activities.
• Participate, support, and recommend from quality perspective on global sourcing and segmentation strategies, including business continuity, benchmarking, new markets, request for quotation (RFQ)/ request for information (RFI), sourcing, selection, cost savings and other analytics.
• Lead technical risk assessment audit for new supplier/ material engagement or qualification to assess their capability and readiness for High Volume Manufacturing (HVM).
• Set up, communicate, and ensure suppliers understood and comply with Micron Supplier Requirements Standards (SRS).
• Support cross fab technology transfer activities in terms of new technology Bill of Materials (BOM) and driving global specifications alignment.
• Collaborate with Suppliers on their outgoing analysis capability to align Best-In-Class (BIC) method detection.
• Align and guide Suppliers to aligned Fab’s advance technology needs which include but not limited to:Study BIC test analysis method and align with Supplier with the collaboration with site Chem Lab to support manufacturing needs (FOAK eval, routine quality monitoring, troubleshooting, improvements, etc.).
  Align, correlate, document with suppliers on lab methods / tools / practices and target to achieve low detection at ppq level contamination.
  To provide a platform for technical or knowledge sharing for SQE team.
  Conduct Regular Technical Meetings with Suppliers on metrology CIPs.
  Conduct constant look out of advance chemical analytical equipment and technology, work with internal site/supplier on results correlation and deploy into CIP with suppliers in compliance to advance technology
  Conduct research for ≤ 10nm particle detection and work with internal site/supplier on results correlation, and deploy into CIPs with suppliers in compliance to advance technology
  Lead Suppliers towards ISO17025 compliance.
  
• Set up, communicate, and ensure suppliers understood Micron metrology expectations.
• Support Category Strategy for Benchmark to/with Suppliers to ensure Controls and Preventive measures are in place to support Shift-Left-Strategy. Supplier/Material development programs.
• Participate and support test method benchmarking and analytics with Suppliers

2. HVM Phase - Supplier Development and Excursion Management

• Lead Wet Chemical and Specialty Chemical Global Material Specification definition and alignment activities with internal stakeholders and suppliers.
• Deploy Wet Chemical and Specialty Chemical category Quality programs, lessons learnt and benchmark to/ with suppliers to ensure controls and preventive measures are in place to support Shift-Left-Strategy.
• Host regular Quality and Technical Review (QTR) meetings with strategic and developing suppliers.
• Manage supplier and sub-supplier changes in Supplier Change Management (SCM).
• Work collaboratively with Global OCT MTE, Operations and Facility globally for deep dive root cause investigations, corrective and preventive actions to ensure no recurrence of related Quality issues.
• Define, manage, and monitor supplier monthly quality performance metrics and their compliance to Micron SRS.
• Enhance the supplier quality business processes to improve productivity and efficiency.
• Support Global Procurement on supplier performance rating on Quality related criteria.
• Lead and conduct supplier audit.

Experiences:

• Previous experience working in Chem lab, wet chemical and specialty chemical under semiconductor industry field is preferred
• Basic Knowledge of ISO9001, IATF16949 & ISO17025 requirements.
• Basic knowledge of Wet Chemical and Specialty Chemical applications and wafer manufacturing process.
• Strong analytical skills with experience in MSA and calibration, statistical methods, FMEA, problem solving methodology and quality management systems.
• Ability to interact effectively with internal and external interested parties, across all levels.
• Ability to collaborate effectively with cross-functional organizations to understand needs and translate them into actionable plans, deliverables, and resource requirements.

Qualification:

• Minimum of 5 years’ in semiconductor field.

Develops, evaluates, revises, and applies technical quality assurance protocols/methods to inspect and test in-process raw materials, production equipment, and finished products. Ensures activities and items are in compliance with both company quality assurance standards and applicable government regulations. Performs analysis and identifies trends in the inspection of finished products, in-process materials and bulk raw materials, and recommends corrective actions when necessary. Ensures that established manufacturing inspection, sampling and statistical process control procedures are followed. May assure compliance to in-house and/or external specifications and standards, such as GMPs and ISO regulations. Evaluates and analyzes the efforts in organizing, documenting, and interpreting inspection support documents and records.

Leading Ice Cream and Gelato Manufacturer Singapore.

As Singapore’s leading homegrown manufacturer of halal certified ice cream, gelato and sorbets for over 21 years, we supply a diverse range of clients with our premium products. Selling both locally and internationally, we are committed to making sweet memories with food. From our 18,000 sq. ft. factory, we produce classic and create bespoke flavours for our clients. Our products are also available wholesale under our brand Oishi, Artisertz or as OEM.

Job Title: Ice Cream Production Quality Control Manager

Location: Singapore

Job Summary:
The Ice Cream Production Quality Control Manager is responsible for overseeing the quality assurance processes in the production of ice cream, ensuring compliance with local regulations, such as those set by the Singapore Food Agency (SFA) and international food safety standards. The role entails supervising quality checks throughout the production cycle, implementing corrective actions, and ensuring that the final product meets the highest standards of quality and safety for consumers.

Key Responsibilities:

1. Quality Assurance and Compliance: Develop, implement, and maintain robust quality control protocols in line with SFA regulations, HACCP standards, and ISO certifications (e.g., ISO 22000).
   Ensure compliance with food safety and hygiene regulations specific to Singapore.
   Oversee product testing to ensure the consistency of taste, texture, and overall quality of ice cream products.
   
2. Production Process Monitoring: Supervise the ice cream production process to maintain strict adherence to quality control checkpoints. Collaborate with production and packaging teams to ensure smooth operations without compromising on product quality. Ensure that all equipment is regularly inspected, calibrated, and meets the required standards.
   
3. Health and Safety Compliance: Ensure compliance with Singapore’s Workplace Safety and Health (WSH) Act and other relevant health regulations. Conduct regular health, hygiene, and safety inspections across the production facility. Train staff specific food safety and hygiene practices, ensuring compliance with regulatory guidelines.
   
4. Issue Resolution and Continuous Improvement: Investigate and resolve any production or quality issues by leading root-cause analysis and corrective actions. Implement continuous improvement initiatives to enhance production efficiency and quality control. Track, document, and analyze production quality data to improve processes and reduce wastage.
   
5. Supplier and Ingredient Quality Management:Evaluate and ensure that all raw materials, including dairy and flavoring agents, meet strict quality standards. Collaborate with procurement teams to assess supplier performance and adherence to quality requirements. Work closely with suppliers to address quality issues and ensure consistent delivery of high-quality ingredients.
   
6. Documentation and Reporting:Maintain comprehensive records for all quality control processes, inspections, and corrective actions in compliance with local regulatory requirements. Prepare and submit reports on production quality and compliance to internal management and regulatory bodies, including the SFA. Coordinate audits and ensure that all documentation complies with local and international standards.
   
7. Innovation and Best Practices: Keep up-to-date with trends in the food industry and integrate innovative practices in ice cream production and quality control. Implement industry best practices to improve efficiency, reduce costs, and maintain product quality.
   

Qualifications:

• Bachelor’s degree in Food Science, Dairy Science, Microbiology, or related field.
• Minimum of 5 years of experience in quality control in food manufacturing in the dairy or ice cream sector.
• Strong knowledge of Singapore’s food safety regulations, HACCP principles, and ISO standards (ISO 22000, etc.).
• Excellent communication and problem-solving skills.

Essential Duties and Responsibilities:

1. Quality Assurance and Control:

• Develop, implement, and maintain quality assurance plans, procedures, and control measures.
• Monitor and analyse production processes to detect and resolve quality issues.
• Ensure compliance with relevant regulatory requirements, including FDA, ISO 13485, and other applicable standards.
• Support internal and external audits and regulatory inspections.
• Investigate and resolve product-related issues, deviations, and non-conformities, with the authority to recommend corrective and preventive actions.
• Ensure the non-conformance or quality issue is resolved and complete in a timely manner.
• Participate in new product introductions to ensure quality is built into all products early in their life cycle
• Support validation processes including IQ, OQ, PQ, process validation and test method validation.

2. Process Improvement

• Identify opportunities for process improvements to enhance product quality and manufacturing efficiency.
• Lead and drive QA initiatives across the product areas
• Lead or participate in root cause analysis and corrective action planning.
• Support and drive cost improvement project

3. Customer Interaction:

• Address customer complaints and feedback related to product quality.
• Work closely with customers to understand their quality requirements and ensure that products meet their specifications.
• Communicated on any potential change request of the processes to customer.
• Provide technical support and quality-related information to customers.

4. Documentation and Reporting:

• Maintain comprehensive records of quality control activities, inspection results, and non-conformance reports.
• Prepare and support monthly / annual quality reports to management and other stakeholders.
• Ensure proper documentation and traceability throughout the manufacturing process.

5. Training and Development:

• Train manufacturing staff on quality standards, procedures, and best practices.
• Promote a culture of quality and continuous improvement within the organization.

Education/Experience and Qualifications:

• Degree in Engineering or science, with 2 - 5 years of progressive Quality responsibility, preferably in medical device / pharmaceutical manufacturing.
• Diploma holders in Engineering or science with more than 5 years' experience in Quality are welcomed to apply
• Knowledge of regulatory requirements and quality standards, including FDA regulations and ISO 13485 standards.
• Strong analytical and problem-solving skills, with the ability to troubleshoot complex issues.

Responsibilities

• Perform incoming/ outgoing / in process quality checks and control
• Perform daily inspection on sanitation, hygiene, food safety and quality aspects to ensure good manufacturing and good hygiene practise at work.
• Conduct routine microbial and shelf life testing
• Provide production staff training in GMP, GHP, and CCP.
• Endure adherence to SFA requirements and ISO&HACCP documents are properly carried out
• Develop and recommend improvements of facilities, equipments and procedures to enhance safety, quality and efficiency
• Handle internal/ external audit and liaise with SFA for import and export inspection
• Any other ad hoc duties as assigned.

Requirement:

• Candidate must possess at least Diploma, equivalent or above in Food Science
• Bilingual in English and Chinese to liaise suppliers from China
• Preferably 1 year(s) of working experience in the related field is required for this position.
• Knowledge in food safety & quality audits will be an advantage
• Able to work independently, self-motivated, initiative and able to communicate effectively with all levels

Job Descriptions:

- To support in ensuring the product quality in satisfying company and customer need and requirements

- To support in ensuring quality control through documentation such as maintaining of QC report, SOP specifications and test methods are available.

- Perform internal and external audit to compliance with QMS requirement.

- Support Production on all quality-related activities, including working closely with supplier and Engineering

- Participate in investigations and ensure CAPA findings, risks, recommendations, Non-Conformances reporting and outcomes are appropriate and are clearly documented and communicated

- Oversee implementation and improvement of IQC, IPQC, OQC process related to customer's products in a timely, efficient, and effective manner.

Requirement : -

- Ability to work under pressure

- Experience in Quality control under semi-conductor manufacturing equipment.

- Able to work independently

- Minimum Diploma qualification

- Able to work late if require.

1. Review and refining existing process flow, and process failure mode and effect analysis (FMEA)
2. Optimizing existing standard operating procedure for quality inspection, cycle time for inspection activities & calibration schedule program.
3. Data trending of quality complains & defect, NC & CAPA through use of SPC.
4. Ad-hoc activities for LHR review and documentation.