Total 16 site engineer job vacancies in Quality Assurance / Control category in D27 Yishun, Sembawang

This position will require the candidate to perform the tests of Instruments with Embedded and Networked subsystems using both automated and manual testing techniques.

The successful candidate will display a strong sense of ownership, motivation, and attention to detail.

Responsibilities:

• Responsible for designing, developing, and implementing robust white box test cases to ensure the quality and reliability of our software products.
• Write and execute manual and automated firmware tests by using Python. Carefully analyze and document test results.
• Support Illumina’s Diagnostics/Clinical platforms.
• Contribute to the test automation effort on multiple instruments and networked subsystems that power Illumina’s industry-leading DNA sequencing devices.
• Responsible for test reporting, quantitative and qualitative analysis of test data.
• Conduct testing of FPGA designs using various tools, identify issues, and collaborate with the development team for efficient debugging.
• Work with firmware senior testers and developers to drive all aspects of the firmware testing process for the team in Agile environment.
• Learn and have fun with some of the smartest cross functional engineers in Product Development

All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.

Education:

• BS, MS in CS, EE, ME, Biomed., Bioeng., Bioinformatics, or related engineering field, or equivalent experience

Requirements:

• 0 - 2 years of experience in V&V, the software test/development field, with firmware/embedded SW experience.
• Experience in knowing embedded software test concepts, developing test cases, and using engineering analysis to test the edge conditions.
• Experience in white box testing using Python programs or knowing Pytest to perform firmware tests with TCP/IP interface.
• Able to understand firmware written in C
• Some experience with RTOS and OS: Linux and Windows
• Able to read PCB schematics and troubleshoot problems using lab equipment including JTAG tools, Wireshark, multi meters, oscilloscopes, etc.
• Able to understand the firmware requirement and architecture related to firmware tests.
• Knowledge of FPGA technologies and FPGA testing methodologies.
• Good problem solving and troubleshooting skills.
• Knowledge of Linux application test with shell scripts and test automation is a plus

All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.

• Create ATE (Advantest SmarTest PS1600 & EXA Scale) test program and integrate various test functions in test flow to support First Silicon bring up for wafer and package in NPI phase.
• Perform design validation/characterization/experiment on ATE across process, voltage, frequency and temperature. Evaluate test and product margins, debug and communicate result/yield/analysis to various teams.
• Utilize ATE test tools and other test instrument to debug and analyze the test, design and product issue.
• Support ATE test hardware design (Including build instruction, SI/PI...etc.) and debug.
• Support test time reduction.
• Support proto demands/qualification for IP owner and customer requests.
• Complete test development, test program transfer and product release at respective milestones.
• Initiate, plan and execute multiple projects to achieve target.
• Good knowledge of product engineering, failure analysis and manufacturing test process.
• Interest in learning, researching, sharing and implementing new technology and test methodology.
• Good written/Oral communication skills.
• Result orientated and team work.

Job Responsibilities:
- Maintains the Company Integrated Management System, ensuring all business processes are documented, have a designated owner and a plan for their maintenance, aligned to Survitec strategy and associated accreditation and/or regulatory frameworks.

- Perform internal audit procedure and schedule as per Department audit plans, to include the audit Scope, Objective and Criteria. Deliver the audit report including findings; agree on corrective actions with auditees and refer findings to the Manager.

- Investigate non-conformances using current and appropriate methods, systems, and procedures, taking action to solve immediate compliance issues.

- Identifies shortcomings in quality processes or outputs, identifies root cause and works with internal stakeholder to adjust processes or working practices to remove or mitigate any production quality issues; uses established change management programs to address issues and deliver sustained improvements.

- Attend aviation related training and create/refresh and update on internal company aviation training notes.
Conduct internal company training as per aviation requirements.

- Implements systems to ensure compliance with QHSE policies, group and Customer requirements; ensures audit, inspection and risk management are adhered to and embedded throughout the system.

- Document control system management, revision and updating.

- Defines and communicates the processes and schedule for audit, working with colleagues from the Quality function to ensure all supplier, operational, technical, health, safety and environmental audit activity is carried out as planned.

- Leads and participates in quality, non-conformance and customer complaint investigations.

- Provides written reports on audit and investigation findings, implements and monitors CAPA and improvement actions. Ensures findings are reported and escalated appropriately.

- Works with Survitec QHSE colleagues to develop tools and dashboards for the statistical analyses on which recommendations for improvement are based. Ensures outputs from QHSE reporting tools and dashboards are communicated to and understood by the business.

- Inform manager of audit findings and compliance issues, including capability gaps, workflow issues or matters requiring quality development or improvement.

- Any others tasks/projects as assigned by line manager from time to time.


Job Requirements:
- Degree/Diploma in Engineering (preferably Quality Engineering).

- At least 2 years of Quality Assurance experience in Aviation industry.

- Knowledge of ISO 9001, ISO 14001, and TS 16949.

- Proficiency in statistical tools and Microsoft Office.

- Strong analytical, problem-solving, and communication skills
Certified Internal/Lead Auditor (preferred).

- Train the trainer qualification will have added advantage.

Position Summary

This position is involved in Supplier Quality activities that improve, monitor and measure Illumina’s compliance with the Quality System Regulations, Illumina Quality policies, FDA regulations and ISO standards as well as Illumina product quality for current operation and compliance objectives.

Responsibilities:

• Support qualification of new Suppliers and Partners for materials and services including risk assessments, audits and other supplier on-boarding activities
• Provide support to investigation teams in determining root causes on material quality issues and initiate/ensure corrective and preventive action plans are developed and executed
• Interface with Suppliers/CM (Contract Manufacturer), Engineering / Manufacturing / Quality Assurance / Procurement departments to drive for quality improvements, specifically on incoming rejects, workmanship defects and primitive failures
• Participate in Quality review activities with supplier/CM to identify improvement opportunities to meet quality expectation
• Compile, evaluate and report on supplier/CM quality performance metrics for scorecard and monitoring
• Monitor to ensure supplier’s preventive and corrective actions are implemented and effective
• Participate with NPI team in selection of new suppliers

Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.

Position Requirements:

• Bachelor’s Degree in Engineering, Life Sciences, or related field with 1-3 years of relevant experience
• Experience in driving suppliers to improve quality performance
• Experience in conducting supplier audits
• Good understanding of FDA regulatory environment (CFR 820), 501k and ISO 13485 strongly preferred.
• Experience in medical device / pharmaceutical / IVD is preferred
• Developing basic knowledge of quality tools
• Beginner to intermediate experience with Microsoft tools and spreadsheets, charting, graphing tools and presentation tools.
• Experience with electronic production life (PLM), enterprise resource planning tools (SAP) and etc are preferred
• Experience with statistical analysis packages, eg, JMP, Minitab are preferred
• Detailed oriented, well organized and able to work independently and in teams.
• Good communication and collaboration skills
• Ability to travel as needed

All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.

Our vision is to transform how the world uses information to enrich life for all.

Micron Technology is a world leader in innovating memory and storage solutions that accelerate the transformation of information into intelligence, inspiring the world to learn, communicate and advance faster than ever.

This position focuses on strategy and modeling creation, improving global standardizations, enable sustainability through automation, synchronizing the processes and scaling the solutions to transform the inline interdiction and operation system automation for RAM Quality and Operation Engineering sections.

Responsibilities:

• Establish and improve BKM (Best Known Method) for RAM quality defense line, sampling methodology, sampling systems and operation efficiency.
• Improve quality and yield performance by reducing defect OOC% variation.
• Keen to learn new skills, initiate proactive and continuous improvement projects, in areas across the Front-End including manufacturing methods and processes, quality, software systems, cycle time, key tool metrics (utilization, and performance efficiency), maintenance and routine tasks, and other manufacturing support operation.
• Establish metrics that can efficiently audit adoption rate and compliance to business process, BKM and strategy and perform audits.
• Perform quality deviation investigations, fab metrics benchmarking analysis and find opportunity for improvements.
• Lead and facilitate discussion to drive network alignment on strategy business process and roadmap to achieve area objectives and deliver to timelines/commitments. Ensure BKM sharing spans across all sites regardless of technology and/or site mission differences.
• Actively provide recommendations to improve and optimize programs and processes to the respective program and/or process owners.
• Provide tactical support and coordination for the Fabs for issues of People, Safety, Yield, Quality, Cost, and Cycle Time when required.

Qualifications & Skills:

• Good communication skill, maintain a strong and open relationship with peer group and appropriate team members in other functional areas such as Process Integration Engineering, Quality Systems, Production Operations Management and present strategy and updates to network members and leaders.
• Proficient in project management with good resource planning, status monitoring and deliver timely results.
• Promote worldwide sharing and transfer of area-specific knowledge.
• Proficiency, experience, and knowledge relating to product and test wafer capacity modeling, wafer at risk modeling, Failure Mode Effect Analysis (FMEA) concept and system, defect analysis tools, sampling strategy and systems, Statistical Process Control (SPC) tools, Cycle Time Management, tableau creation, SQL and Programming language and Organizational Change have advantage.

Education and Experience:

• Masters/bachelor’s in engineering
• Relevant working experiences in RDA and/or Metrology
• Willing and capable of international travel, including Extended International Business Travel (EIBT) assignment to 6 months as needed, to accomplish the goals.

Maximizes yield by working on tools, the process, or wafer fabrication recipes. Troubleshoots wafer fabrication problems and performs root cause analysis. Works with other process areas to understand and control process deviations. Long-term investigation of defect issues may require extensive work with shift engineering and other functional areas. Evaluates products to ensure they meet the required design and performance specifications. Conducts research to assess process adjustment requirements and recommends process improvements or equipment changes needed to efficiently manufacture new product or part types.

Responsibilities

• Manages & leads a team of engineer assistants, supervisor and technicians on the testing of low-voltage switchboards and power distribution boards.
• Ensures that all testing checklists are correctly checked and signed.
• Drafts training material, manages and provides training (safety guidelines, testing and troubleshooting techniques) for newly hired employees or on new products.
• Leads the team and conducts factory acceptance tests (FAT) / factory witness tests (FWT) with the presence of clients in accordance to the method of statement (MOS).
• Performs in-house test procedures in accordance with the MOS.
• Performs in-house quality control procedures and checklists (e.g., visual inspection, torque tests, etc).
• Manages (calibration, defect reports, replacement procedures) all relevant tools and equipment used by the Testing Department.
• Assists in providing insights to the Quality Management Team for CAPA and RCA whenever required.
• Assists in providing insights to the Project Management Team for discussions and validation of the method of statement whenever required.
• Be committed to the team in achieving various goals set by the Managements

Requirements

• Diploma and/or above in Electrical Engineering, Electrical & Electronic Engineering or Mechatronic Engineering.
• Well versed in Microsoft Office tools (Outlook, Teams, Word, Excel, etc.).
• Possesses the ability to interpret electrical schematic, single line diagram (SLD).
• Preferably to be experienced in handling tools and equipment used in electrical testing (E.g., Primary Current Injection Test Set, Secondary Current Injection Test Set, Digital Micro-Ohm Meter, Insulation Resistance Test Set, Dielectric Withstand Test Set).
• Minimum 1 year of related work experience* in the field of Electrical Engineering.

Job Responsibilities:
- Maintains the Company Integrated Management System, ensuring all business processes are documented, have a designated owner and a plan for their maintenance, aligned to Survitec strategy and associated accreditation and/or regulatory frameworks.

- Perform internal audit procedure and schedule as per Department audit plans, to include the audit Scope, Objective and Criteria. Deliver the audit report including findings; agree on corrective actions with auditees and refer findings to the Manager.

- Investigate non-conformances using current and appropriate methods, systems, and procedures, taking action to solve immediate compliance issues.

- Identifies shortcomings in quality processes or outputs, identifies root cause and works with internal stakeholder to adjust processes or working practices to remove or mitigate any production quality issues; uses established change management programs to address issues and deliver sustained improvements.

- Attend aviation related training and create/refresh and update on internal company aviation training notes.
Conduct internal company training as per aviation requirements.

- Implements systems to ensure compliance with QHSE policies, group and Customer requirements; ensures audit, inspection and risk management are adhered to and embedded throughout the system.

- Document control system management, revision and updating.

- Defines and communicates the processes and schedule for audit, working with colleagues from the Quality function to ensure all supplier, operational, technical, health, safety and environmental audit activity is carried out as planned.

- Leads and participates in quality, non-conformance and customer complaint investigations.

- Provides written reports on audit and investigation findings, implements and monitors CAPA and improvement actions. Ensures findings are reported and escalated appropriately.

- Works with Survitec QHSE colleagues to develop tools and dashboards for the statistical analyses on which recommendations for improvement are based. Ensures outputs from QHSE reporting tools and dashboards are communicated to and understood by the business.

- Inform manager of audit findings and compliance issues, including capability gaps, workflow issues or matters requiring quality development or improvement.

- Any others tasks/projects as assigned by line manager from time to time.


Job Requirements:
- Degree/Diploma in Engineering (preferably Quality Engineering).

- At least 2 years of Quality Assurance experience in Aviation industry.

- Knowledge of ISO 9001, ISO 14001, and TS 16949.

- Proficiency in statistical tools and Microsoft Office.

- Strong analytical, problem-solving, and communication skills
Certified Internal/Lead Auditor (preferred).

- Train the trainer qualification will have added advantage.

Position Responsibilities

• Provide quality assurance support and review areas of manufacturing operations, product development, or field/ product quality.
• Ensure that facilities, equipment, materials, processes and product readiness comply with cGMP practices.
• Serve as Quality representative on project teams for reviewing the new product design transfers and/ or line transfers.
• Review and align manufacturing operational activities, such as Work instructions, Device History Records, Nonconformances, CAPA, RMA, and customer complaint investigations.
• Identify and drive resolution of quality issues in Quality Management System and/ or manufacturing operations.
• Work with cross-functional teams to resolve operational quality issues.
• Trend, analyze and monitor key performance indicators, suggest improvements and escalate to supervisor/ management as necessary.
• Participate in customer complaints and work closely with cross-functional teams to investigation issue and ensure timely response to corporate/ customer.
• Work in accordance with procedures and integrated program plans to achieve and maintain the required level of product quality in preparation for FDA and ISO third party audits.
• Support product risk management activities and ensure quality and completeness of project design history files, validation packages, and change orders
• Review verification and engineering study reports and identify gaps for GMP compliance. Develop and execute strategies to close gaps in an efficient, technical, and compliant manner
• Coordinate issue resolution using a risk-based approach

Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.

Position Requirements

• Minimum of 1-2 years of related experience in manufacturing, quality assurance, and/ or process validation in a regulated environment. Fresh graduates can be considered.
• Bachelor's Degree in Biology, Biochemistry, Chemistry or equivalent field is preferred.
• Experience in the medical devices / IVD / biotech / pharmaceutical industry, or instrument hardware / software integration is an advantage.
• Good interpersonal, verbal and written communication skills.
• Familiar with 21 CFR 820 and ISO 13485 requirements.
• Familiar with words processing, spreadsheets and presentation tools.
• Familiar with failure investigation, technical report writing, data mining, trend analysis and statistical analysis.
• Adaptable to fast-paced, dynamic work environment with shifting demands
• Ability to operate with high level of independence to investigate and resolve compliance issues, lead projects, plan and implement improvements, and achieve goals.

All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.

Responsibilities

1.Regulatory and Compliance Leadership:

· Serve as the primary point of contact for all regulatory and compliance matters related to Offshore Wind and Offshore Substation projects

· Develop and maintain a comprehensive understanding of international and local regulations, including environmental, local regulation such as BOEM, safety, and maritime regulations.

· Stay abreast of regulatory requirements, flag requirements, and industry best practices, developing and updating regulatory compliance plans,policies, and procedures.

2. Regulatory Review and Documentation:

· Conduct regulatory reviews of offshore substation designs and documentation to ensure compliance with relevant standards and regulations.

· Prepare and submit regulatory compliance documents, assist and collaborate with developer and/or client to provide input for permit applications, safety cases, and environmental impact assessments where require.

· Review and analyze reports from third-party consultants, providing critical feedback and recommendations.

3. Team Management and Development:

· Lead and mentor a team responsible for regulatory compliance and technical safety, setting objectives, monitoring performance, and providing career development guidance.

· Direct the team's progress in delivering regulatory requirements, plans,and reports, ensuring these are integrated into the design at an early stage.

· Manage the transformation of contractual specifications into cost-effective engineering solutions, following relevant codes, standards, and classification requirements.

4. Project Coordination and Support:

· Collaborate with other engineering disciplines (e.g., E&I, Piping,Mechanical) on problem areas related to regulatory compliance and technical safety.

· Provide regulatory compliance to commercial marketing, bidding, and procurement activities during pre-contract and contract development phases of Offshore wind and substation projects.

· Manage team coordination on design changes, ensuring follow-up on regulatory updates.

5. Interface and Liaison:

· Liaise with regulatory bodies, classification societies, third parties andother relevant authorities to obtain necessary approvals and certifications.

· Manage relationships with external consultants, regulatory specialists, and internal departments to ensure a holistic approach to compliance.

6. Strategy and Program Development:

· Develop and implement compliance strategies and programs to meet regulatory requirements and industry best practices.

· Initiate the development of compliance matrices to maximize team performance, accuracy, and design compliance.

· Contribute to the development of company policies and procedures related to regulatory compliance.

7. Risk Management and Auditing:

· Conduct internal audits to assess compliance with regulatory requirements and company policies specific to offshore wind and substation projects.

· Manage the development and maintenance of a recommendation register, ensuring that feedback from safety studies is integrated into project designs.

8. Reporting and Communication:

· Prepare regular reports on compliance status and regulatory risks for Project Engineering Manager.

· Review team reports for accuracy and liaise with customers, statutory, and classification authorities on design and compliance issues affecting production start-up.

9. Training and Development:

· Develop and deliver training programs to ensure staff awareness of regulatory requirements and compliance procedures.

· Provide career development guidance and routine administrative responsibilities, such as leave and course approvals.

Requirements

· Bachelor’s degree in electrical engineering, Marine Engineering, Environmental Science, or related field, an advanced degree is preferred.

· Minimum of 5-7 years of experience in regulatory affairs and compliance within the offshore industry.

· In-depth knowledge of international and local regulations applicable to offshore wind engineering and substation design.

· Strong understanding of risk assessment and management principles.

· Experience in preparing and submitting regulatory compliance documents and permit applications.

· Familiarity with technical aspects of offshore wind and Offshore substations, including high voltage systems, grid connection requirements, and marine engineering considerations.

· Proven experience in leading teams, mentoring, and guiding junior engineers.

· Excellent analytical, problem-solving, and communication skills.

Our Addresses and Working Hours:

Seatrium (SG) Pte. Ltd.

(Amiralty Yard)

60 Admiralty Road West, Singapore 759947

Mon - Thu: 8:00am - 5:15pm

Fri: 8:00am - 4:30pm

Interested candidates are invited to send us an updated resume with your current and expected salary and earliest availability.

We regret that only shortlisted candidates will be notified.

Please note that your personal data disclosed to Seatrium (SG) Pte. Ltd. and our group of companies, shall be used for the purposes of evaluation, and processing in accordance with our recruitment processes and policies. By providing your personal data, you have consented to the aforesaid purpose under the provisions of the Personal Data Protection Act 2012.

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.

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

Job Responsibilities

• Disposition of Fab lots affected by planned or unplanned deviations (including those from Special Work Requests and Fab Conversions, or from Quality Deviations and Excursions).
• Work closely with Fab partners to identify and contain excursion material. Initiate and lead multi-functional MRB (Material Review Board) to conduct risk assessment and decide upon disposition of excursion material.
• Review and analyze proposed process conversion changes to ensure that the proposed manufacturing changes conform to current business standards, improve Micron’s competitiveness in terms of wafer yields and costs, and protect Micron’s product quality.
• 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.

Requirements

• Bachelor's Degree in Electrical or Chemical Engineering, Material Science, Physics and 3+ years of semiconductor industry experience
• Knowledge of Electrical and Physical Failure analysis of semiconductors
• Knowledge of semiconductor memory product and reliability testing
• Strong understanding of NAND FLASH operation and structure
• Intermediate understanding of wafer fab manufacturing process steps, functional probe and parametric testing methodologies
• Excellent statistical data analysis, troubleshooting and decision making skills
• Proven track record to work effectively in both an independent role and in team environments
• Excellent multi-tasking and problem solving skills
• Intermediate PC skills including MS Office Word, Excel and PowerPoint
• Ability to clearly communicate data and findings both verbally and in writing.

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.

Key Job Accountabilities (Actual daily deliverables):

• Co-ordinate / Execute new product offloads plan
• Interface with customer on product offloads and provide assessment and information on test capabilities and providing resolutions to barriers/constraints
• Performs required test correlation, evaluation, and test characterization on new product offloads, and shall communicate to customer the test results or if any- test correlation issues and resolutions
• Generate Test Setup Specification based on customer’s test requirements for production to support the product
• Evaluate and recommend process change/s for improvements to help improve yield, quality, and cycle time
• Provide required test support needs by Engineers
• Sustain test program, hardware and major setup issues in mass production

Required Qualifications:

• Diploma in Electronics / Electrical Engineering or its equivalent
• Minimum 2 years of experience, preferably experience in semiconductor or subcontracting industry
• Fresh graduates are welcome to apply

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.

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.