Quality Assurance / Quality Specialist / Quality Engineer

Company Overview

Location: Kranji (near MRT with a 5-minute shuttle bus)

Number of Openings: 9
Duration: 6-month
Salary: up to 8K

Job Responsibilities:

1. Documentation and Quality Oversight:Revise, review, and approve SOPs, MBR/EBR, and QO documents.
   Provide quality guidance and support to the manufacturing team, addressing quality queries and issues.
   
2. GMP and Compliance:Conduct quality oversight activities, including GEMBA and GMP walks.
   Adhere to and enforce cGMP and regulatory requirements, especially for FDA and EU compliance.
   
3. Qualification/Validation Support:Perform IQ/OQ tasks and assist in validation activities including Data Integrity, Analytical Instrument Qualification, Analytical and Microbiology Method Validation, and Critical Reagent Qualification.
   Review and approve related protocols, reports, and ensure alignment with regulatory requirements.
   
4. Project Involvement and Collaboration:Act as the Quality Representative in cross-functional projects.
   Provide validation expertise and maintain Master Validation Plans.
   Collaborate on multi-site initiatives to harmonize Quality Systems across plants.
   
5. Documentation Integrity and Inspection Readiness:Ensure documents are clear, compliant, and defendable during audits.
   Support multisite initiatives to align validation activities across locations.
   
6. Other Responsibilities:Build and maintain partnerships with internal departments.
   Adhere to EHS requirements and Shire’s Code of Conduct.
   

How to Apply: Send your resume to Jocelyn Chan at [email protected] or contact via Telegram @jocelynchan.

Jocelyn Chan | Consultant | Recruit Express Pte Ltd (Healthcare & Lifescience) Company EA Licence Number: 99C4599 Personnel EA License: R1331820

-Familiar with usage of commonly-used QC testing / measuring instrument

-Organised, methodical, meticulous, pro-active

-Visual Inspection

-Able to follow through with colleagues and vendors in a firm manner to ensure quality requirements are upheld and faults rectified

-Responsible, team player, able to communicate and integrate

-Adhoc duties may be assigned

-Perform product inspections, in-process inspections, and Final inspections prior to delivery

-Prepare QC reports

-Communicate in-house and with vendors and products faults, and follow up to ensure rectification

-Familiar with usage of commonly-used QC testing / measuring instrument

-Organised, methodical, meticulous, pro-active

-Visual Inspection

-Able to follow through with colleagues and vendors in a firm manner to ensure quality requirements are upheld and faults rectified

-Responsible, team player, able to communicate and integrate

-Adhoc duties may be assigned

-Perform product inspections, in-process inspections, and Final inspections prior to delivery

-Prepare QC reports

-Communicate in-house and with vendors and products faults, and follow up to ensure rectification

-Familiar with usage of commonly-used QC testing / measuring instrument

-Organised, methodical, meticulous, pro-active

-Visual Inspection

-Able to follow through with colleagues and vendors in a firm manner to ensure quality requirements are upheld and faults rectified

-Responsible, team player, able to communicate and integrate

-Adhoc duties may be assigned

-Perform product inspections, in-process inspections, and Final inspections prior to delivery

-Prepare QC reports

-Communicate in-house and with vendors and products faults, and follow up to ensure rectification

1. Able to read and understand technical drawings.
2. Must able to do Mitutoyo CMM Programming and Operation.
3. Ensure incoming materials, in-process production and finished products meet by confirm specifications requirements; conducting visual and measurement tests.
4. Follow up corrective actions in production
5. Documents inspection results by completing reports and logs; inputting data into quality database.
6. Able to perform final inspection report for finished products and prepare relevant documents to customer.
7. Evaluate and analyze customers rejections, implement and feedback corrective action.

• At least 5 years' experience in Quality Control
• Basic Computer knowledge to prepare Quality Documents Report
• Able to speak, write and read simple English
• Able to work independently with minimum supervision

Work Location: Tuas Biomedical Park

Responsibilities:

Responsible for routine operation of QC lab, including but not limited to:

• Manage the routine operation of QC team to ensure the business delivery at the right quality, cost and speed.
• Management several sub-teams like product testing group, and microbial group
• Lead the team to comply with internal requirements in all aspects via end-to-end quality control system oversight
• Ensure all the activities in QC team performed with compliance of cGMP, data integrity and EHS requirement
• Provide support and technical directions for any technical/experiment work required during investigation and definition of corrective and preventive actions
• Oversight of the training, evaluation and management of the staff in QC lab. Coaching, developing and supporting them in reaching their full potential
• Responsible for the GMP audit from regulatory authorities and clients. Reply to audit reports and create CAPAs

Qualifications:

• Bachelor's degree or above in pharmacy, chemistry, biochemistry, analytical chemistry or other related disciplines
• Minimum 7 years of experience in biotech or biopharma industry
• A good understanding of the overall view of the drug development process
• A thorough understanding of the principles and management of cGMP compliance, and a strong quality mindset
• Comprehensive knowledge of FDA, EMA, NMPA, ICH, WHO technical guidelines, and USP, Eur.P, ChP pharmacopoeias
• Comprehensive knowledge of IND/IMPD, NDA, and ANDA filing

• Well Established Company
• Basic $5000 - $6500 + Allowance + AWS + Variable Bonus
• Excellent Welfare and Benefits + Career progression
• Working location: Boon Lay
• Working day: Monday to Friday
• Working hours: 8.30am to 5.30pm
• QMS | ISO 13485 | Medical Devices

Job Responsibilities:

• Conduct assessment and review on supplier qualification, performance and process capability
• Ensure supplier quality issues are deal with, analysed, improved and follow through
• Collect, handle and follow-up on customer feedback/complaints
• Support internal, external and customer audits
• Evaluation, verification and validation of new parts/samples
• Establish and maintain inspection criteria for incoming, in-process and final products
• Identify quality issues, NCR, CAPA handling and drive continuous improvement
• Authorize the release (COC) of products, COA review & approval
• Monthly data analysis on product quality and quality objective
• Review and approval on DHR
• Participate in new projects, commercial product quality management and control
• Drive change management and control
• Other ad hoc duties as assigned

Job Requirements:

• Possess minimum Diploma/Degree in relevant subject area with 2 years’ experience in medical device QA and/or RA
• ISO 13485:2016 certified internal auditor will be advantageous
• Familiar with quality control tools

Candidates are encouraged to apply this position via Apply Now button with the following information in the resume

• Work experiences and job responsibilities
• Current and Expected salary
• Reason for leaving
• Date of availability
• Education background

We regret that only shortlisted candidates will be contacted.

LIONG ZHAO GUAN (R22107632)

EA Recruitment Pte Ltd

EA License No: 21C0492

Job Scope:

• Develop and implement quality control procedures and policies
• Conduct inspections and audits to ensure compliance with quality standards
• Monitor and test materials, products, and processes to verify quality
• Identify and resolve quality issues and non-conformance
• Review project specifications, drawings, and standards for quality requirements
• Prepare quality reports and document test results and inspections
• Coordinate with suppliers and subcontractors to ensure quality requirements are met
• Perform root cause analysis for quality failures and implement corrective actions
• Ensure that safety and environmental standards are followed during inspections
• Train and mentor staff on quality control processes and best practices
• Maintain records of quality inspections, certifications, and test results
• Support project managers in quality planning and control
• Ensure continuous improvement in quality processes and systems

Requirements:

• Engineering degree
• 5+ years of QA/QC experience in construction
• Experience in structural steel or precast RC works
• Strong interpersonal and communication skills

Interested candidates who wish to apply for the advertised position, please click on the APPLY button below to send in your resume to [email protected]

EA License No: 13C6305

Reg. No.: R1981808

For candidate who applied for the advertised position is deemed to have consented to us that we may collect, use or disclose your personal information for purpose in connection with the services provided by us.

• Well Established Medical Devices Manufacturing Company
• Basic $2300 - $3000 + Allowance + AWS + Variable Bonus
• Excellent Welfare and Benefits + Career progression
• Working location: Boon Lay
• Working hours: 12 Hours Shift

Job Responsibilities:

• Carry out inspection of incoming materials and finished products according to operational instructions to ensure that materials or products meet the requirements
• Ensure product identification is correct and stored in the correct location, maintenance of inspection equipment and daily monitoring of production environment
• Statistics on the quality status of incoming materials and processes and the quality of shipped products
• Report abnormalities to superior in timely manner and inform relevant departments and track the improvement status of non-conformities
• Assist in customer complaint analysis and take corresponding improvement measures
• Ensure records comply with good writing practice GDP requirements
• Assist the superior to complete other tasks

Job Requirements:

• At least 1 year of quality management experience and basic computer software
• Blueprint reading capabilities, and ability to use measuring devices like gauges, meters, calipers
• Documentation and reporting skills

Candidates are encouraged to apply this position via Apply Now button with the following information in the resume

• Work experiences and job responsibilities
• Current and Expected salary
• Reason for leaving
• Date of availability
• Education background

We regret that only shortlisted candidates will be contacted.

LIONG ZHAO GUAN (R22107632)

EA Recruitment Pte Ltd

EA License No: 21C0492

Job Description

• Working with Process Engineer & Engineering team on QC requirement
• Documenting inspection criteria and quality plan
• Work with QA, Process and Product team on corrective action with quality issue
• Work with Process team on in-process audit and FQC audit

Job Requirements:

• Minimum Diploma in Manufacturing /Quality Engineering
• At least 1 year of relevant working experience in Electronics Product Manufacturing environment
• Control of Supplier Quality Assurance (SQA)
• Quality control of in-coming, in-process and out-going products
• Knowledge of ISO 9001, 14001, 13485 & 45001, FDA requirement
• Able to understand IPC requirement in PCB
• Assembly, quality requirement of plastic molding, die casting, extrusion, metal stamping and machining parts

*Please be notified that only shortlisted candidates will be notified*

By submtting your personal data and/or resume, you give consent to the collection, use, and disclosure of your personal data and/or resume by the company (or its agent) for the purpose of the processing and administration by the company relating to this job application.

EA Personnel Name: Chan Jun Wei

EA Personnel No: R1543992

EA License No: 21C0845

The successful candidate will be responsible to develop, implement, and monitor quality control processes for ongoing construction projects and ensure the application of the Lessons Learnt process.

Responsibilities:

Quality Control:

· Lead the creation of a QC process for the region

· Create standardized Inspection and Test plan for projects

· Create standard QC checklists and inspection forms for the projects, supported by the local project teams

· Support the implementation of the forms for all projects

Lessons Learnt /Return On Experience:

· Be the organizer of the REX workshops for tenders and projects

· Create and maintain an accessible, user-friendly REX library

· Ensure the learnings are integrated by the different stakeholders(Project development, projects, management,…)

Requirements:

· Engineering Degree in Thermal, Mechanical or Electrical Engineering.

· Minimum 5 years’ experience in industry, ideally in construction industry

· Minimum 3 years’ experience in Quality Control or Quality Assurance

· Good understanding of Testing & Commissioning activity

· Fluent English is essential (written and oral)

· Good communication skills (to team members, client, contractors, internal management)

· Dare to ask questions, to chase people to get information

· Pro-active

· Self-disciplined and result oriented

·

Roles & Responsibilities

• Generate inspection report, Certificate of Compliance (COC) and other relevant documents required for shipping
• Prepare inspection, Frist Article inspection report, other QC reports as specified in the quality plan
• Use ERP system (EPICOR) daily to accurately move and manage finished goods throughout the plant into inventory
• Convert raw files to PDF format; scan files and electronically store into various databases
• Carry out incoming, in-process inspection, outgoing inspection and planned dimensional checking of products as per quality plan
• Coordinate with production supervisors whenever product quality out of specification
• Any other ad hoc duties as per assigned by superior

Requirements

• Minimum GCE ‘O’ level & above
• Knowlege in basic computer skills, able to write reports, read engineering drawings
• Capable to operate measuring equipment such as calipers, toolmaker scope OGP (preferred but not required)
• Knowledge of quality system such as sampling rules (preferred but not required)
• Able to work as a team player, pro-active, self-motivated and high sense of responsibility.
• Working Location: Ubi area

1. Responsible for I&C engineering related matters.
2. Communicate and coordinate with team and all related stakeholders for planning and scheduling to facilitate smooth commissioning at site.
3. Ensure instrument and control elements installation and wire termination are done correctly and within acceptable standard of workmanship.
4. Enforce PSE and MEP to rectify any substandard works to ensure good quality of works for reliable operation.
5. Lead on-site testing and commissioning of chilled water control system, conduct thorough testing, and validation of control system to ensure proper functionality.
6. Documentation and records of T&C.
7. Handover control system to operation team in timely manner.
8. Respond to operational needs, ensure reliable control and monitoring of control system.
9. Configuration and zeroing of instrument, ensure accurate reading received at control system.

Job Description:

We are looking for an experienced Electrical, Instrumentation & Control Engineer (EIC Engineer) to manage and execute the design, installation, and maintenance of electrical, instrumentation, and control systems across a variety of projects. The ideal candidate will have a strong background in electrical and control systems engineering, as well as hands-on experience with instrumentation, PLCs, SCADA, and DCS systems.

Key Responsibilities:

• Design & Implementation: Design, develop, and implement electrical, instrumentation, and control systems for industrial projects.
• System Configuration: Configure and program PLC, SCADA, and DCS systems to ensure seamless automation and control.
• Installation & Commissioning: Oversee the installation, commissioning, and testing of electrical and control systems on-site.
• Maintenance & Troubleshooting: Perform preventive and corrective maintenance on electrical, instrumentation, and control systems.
• System Calibration: Calibrate and validate instruments to ensure accuracy and proper functioning.
• Safety Compliance: Ensure all electrical and control systems adhere to safety standards and regulations (IEC, NEC, ATEX, etc.).
• Collaboration: Work closely with cross-functional teams, including electrical engineers, mechanical engineers, and project managers, to meet project deadlines.
• Documentation: Maintain detailed documentation of designs, configurations, test results, and maintenance activities.

Qualifications:

• Education: Bachelor's Degree in Engineering, Instrumentation Engineering, Control Systems, or a related field.
• Experience: Minimum of 1 years of experience in electrical, instrumentation, and control engineering, with a focus on industrial applications.
• Technical Skills:Proficient in the design and configuration of electrical systems.
  Hands-on experience with PLC programming
  
• Problem-Solving: Strong troubleshooting and analytical skills in electrical and control systems.
• Communication: Excellent written and verbal communication skills.
• Certifications: Relevant certifications (e.g., Certified Control Systems Technician) are a plus.

Job Description

· Collaborate with cross-functional teams such as Mechanical Engineers, Test Engineers, Lab Technicians, and Project Engineers to execute ocean basin model testing projects, such as floating offshore wind projects.

· Analyse and comprehend project requirements related to hydrodynamic testing, model instrumentation, and data acquisition.

· Select and implement suitable data acquisition systems, control system design, and develop software architecture specific to ocean model testing needs.

· Develop and maintain application software for new ocean basin test setups and custom test requirements.

· Upgrade existing software systems to accommodate new test protocols or methodologies for ocean model testing.

· Choose appropriate sensors for wave, current, and motion measurements, ensuring seamless integration with control systems and software.

· Create and update documentation, including software designs, changes, user manuals, and standard operating procedures (SOPs) for ocean model tests.

· Upgrade LabVIEW-based software applications to newer versions, ensuring they meet the latest testing requirements.

· Troubleshoot and resolve issues in control systems, data acquisition, and software during model testing.

· Test and validate application software before deployment to the ocean basin test setup.

· Prepare comprehensive user manuals, SOPs, and provide training for test engineers to ensure smooth operation of the test environment.

Job Requirements

· Minimum qualification: Bachelor of Engineering (BEng) / Bachelor of Technology (BTech) in Electronics, Electrical, Instrumentation, or Computer Science with at least 2 years of relevant experience, particularly in LabVIEW.

· Proficiency in different versions of LabVIEW, including the latest versions with relevant toolkits.

· Experience in designing and developing NI LabVIEW-based data acquisition and control systems for ocean basin model testing or similar environments.

· Proven ability to develop modular and scalable applications using LabVIEW?s standard architecture.

· Experience in developing LabVIEW applications for Windows and Real-Time (RT) Linux environments.

· Proficiency in integrating NI hardware systems such as PXI, cRIO, and CompactDAQ into the testing framework.

· Hands-on experience with communication protocols like TCP/IP, UDP, Serial, USB, CAN, and EtherCAT for testing and control purposes.

· Experience with integrating third-party programmable instruments (e.g., multimeters, power supplies, oscilloscopes) and controllers into ocean testing setups.

· Experience in developing NI software drivers for third-party hardware and integrating third-party software with LabVIEW.

· Knowledge in selecting, wiring, and troubleshooting sensors used in hydrodynamic and ocean model testing (e.g., pressure sensors, accelerometers, flow meters).

· Experience in reading control panel schematics, designing control systems, and selecting appropriate control panel hardware for model testing.

· Strong team player with the ability to work independently and collaborate in cross-functional project teams.

· Experience interfacing induction motors with VFDs and control systems, with knowledge of VFD configuration for use in testing environments.

· Strong troubleshooting skills at the signal and system level for data acquisition and automated test systems.

· Excellent documentation skills for capturing test requirements, preparing software designs, and writing user manuals.

The above eligibility criteria are not exhaustive. A*STAR may include additional selection criteria based on its prevailing recruitment policies. These policies may be amended from time to time without notice. We regret that only shortlisted candidates will be notified.

Summary of Job Scope:

Responsible for technical enhancement of quality control and analytical development in QC Laboratory functions.

• Work allocation and arrangement for daily QC routine work
• Finish Product Quality Control
• Checking Report of "In-Process control of Tablet"
• In process quality control of intermediates (IPQC)
• Review and evaluation of Analyst test report and data to ensure test result is up-to date and accurate.
• Review and ensure QC Records and BMR are up-to-date, complete and accurate.
• Supervision of quality control check on raw material dispensing
• Management, Monitering and testing on sample.
• Monitor retained samples and waste of tested sample of intermediates and finished products.
• Environment monitoring and recording for retention sample room.
• Supervision and training of laboratory technicians and laboratory assistant and chemist in carrying out their duties.
• Responsibe to revise of SOP for IPQC and FPQC and relevant section.
• Verify and approve test result in absence of QC Manager.
• Calibration of laboratory equipment and apparatus.
• Ensure Good Laboratory Practice (GLP) & Lab Safety.
• Optimization of usage of laboratory equipment.
• Support in the investigation and management of product complaints.
• Participate in process and cleaning validation.

Location: West

Task Management

• Design and execute a comprehensive strategy for enhancing product quality, ensuring alignment with organizational objectives.
• Lead cross-functional teams to identify and address root causes of quality-related challenges.
• Develop and implement corrective and preventive measures to mitigate future quality concerns.
• Monitor and analyze product quality metrics to assess progress and identify opportunities for improvement.
• Conduct regular audits and evaluations to proactively manage potential quality risks.
• Collaborate with suppliers to verify compliance with quality standards and specifications.
• Work closely with teams in engineering, manufacturing, classification bodies, and suppliers to uphold consistent quality throughout the product lifecycle.
• Stay informed on emerging quality methodologies and tools to enhance processes.
• Review and analyze warranty data to support new product enhancements and continuous improvement initiatives.
• Identify and recommend process and product improvements for enhanced performance.
• Anticipate and address quality risks to prevent potential impact on products or operations.
• Deliver regular updates and detailed reports to key internal stakeholders.
• Maintain high standards of quality while ensuring cost control within allocated budgets.
• Provide product familiarization to customers as needed.
• Occasionally travel to operational areas to assess product performance and gather insights for improvement.

Interpersonal Management

• Communicate effectively by actively listening, providing clear information, and delivering constructive feedback across all organizational levels.
• Build strong, trustworthy relationships by demonstrating respect, authenticity, and dependability.
• Coordinate with shipyard personnel and management to ensure product quality aligns with organizational goals.
• Foster and maintain strategic relationships with partners, customers, suppliers, contractors, and regulatory bodies.
• Negotiate effectively on the company’s behalf, finding practical compromises when needed.
• Establish a robust network of industry suppliers, subcontractors, and key contacts.

Information Management

• Oversee the creation and management of quality improvement documentation and reporting.
• Develop a comprehensive understanding of product specifications and performance standards.
• Stay informed on applicable classification and regulatory requirements that influence product quality.
• Manage warranty claims and provide continuous feedback to enhance shipyard processes and products.

Personal Development

• Pursue ongoing professional growth opportunities.
• Take accountability for achieving individual and team objectives.
• Stay current with industry best practices and monitor competitor activities for strategic insights.

REQUIREMENTS:

• At least 7-8 years of experience in management or supervision related to building, operating, or maintaining marine vessels, with a demonstrated history of success.
• Relevant qualifications in marine or engineering fields are highly preferred.
• Advanced skills in negotiation and resolving disputes.
• Strong commercial awareness and business acumen.
• Exceptional interpersonal and communication abilities.
• Proficient in managing record-keeping systems.
• A well-established network of industry suppliers, subcontractors, and contacts is highly advantageous.
• Dedicated to fostering continuous improvement, prioritizing safety, promoting teamwork, and encouraging transparent communication.

If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV or email to [email protected]

CEI Registration Number: R1985071

EA License Number: 21C0661

Company Registration Number: 201127615M

Description:

• Responsible for field instrument and control system design work.
• Able to understand process requirement from P&ID, select suitable process control, safety instrumentation as per the project specifications.
• Participate in the project HAZOP, 3D model review.
• Prepare instrument data sheet, Instrument Index, DCS I/O List
• Prepare construction drawings such as Control system architecture, Instrument Location Plan, hook-up, cable routing, loop diagram, cable schedule.
• Prepare RFQ for various process instruments, vendor technical bid evaluation.
• Preparation of technical proposals, material take-off and cost estimation for tender projects.
• Perform other functions that may be assigned by superior.

Requirements:

• Bachelor’s degree in Electrical and Electronic Engineering or Instrument and Control Engineering.
• 3~5 years’ experience in instrument and control system design work.
• Knowledge and experience in Field Instrument Engineering as well as Control System, e.g. DCS, ESD, F&G.
• Able to work at construction site to support construction, pre-commissioning and commissioning activities.
• Good interpersonal and communication.
• Fresh graduates are also welcome to apply.

Purpose: To create, control and manage changes to customer's Technical Product Data (TPD) packages (Items, Bill of Materials, Product specification documents) in the Product Lifecycle Management (PLM) and Enterprise Resource Planning (ERP) systems. To deploy TPD changes to the relevant Persons-in-Charge (PICs) for execution.

Key Area of Responsibilities:

• Check the correctness and completeness of product packages, such as Technical Product Data (TPD) and Bill of Materials (BOM) received from customers.
• Work with the user of TPDs to define the new TPD requirement and update the ISO document (for new customers or any change in TPD requirement).
• Maintain required customer items, BOM, and TPDs in PLM and ERP systems.
• Create and control the item part number, BOM and TPD in the PLM and ERP systems.
• Create projects in the ERP system for the fulfillment of customer Sales orders.
• Implement Engineering Change Order (ECOs) and deploy the changes to the next inline PIC (such as planner, purchaser, process engineer and Sales & Program dept.)
• Check and ensure all required information for the TPD (items, BOMs, documents) and/or configuration change are provided, and approved by the customer.
• Support and participate in company continuous improvement program.

Qualification & Experiences:

• Diploma/Degree in Mechanical Engineering/Science or relevant field.
• Minimum 2 years of working as a product data engineer in the semiconductor industry or similar position.
• Proficient in Microsoft Excel functions
• Good communication skills

Responsibilities:

• Oversee and able to control group of inspection, leveraging on your manufacturing and QC experience.
• Apply knowledge of QC sampling techniques and operate measuring instruments effectively.
• Conduct QC sampling inspections to ensure compliance with quality standards.
• Prepare samples and perform quality testing as required.

Requirements:

• 1-2 years of relevant working experience in quality control or a related field.
• Strong communication and interpersonal skills.
• Ability to multitask and work in a fast-paced environment.

Other Information:

• Work Schedule: 5-day work week (8:00 AM - 5:30 PM)
• Location: Woodlands.
• Transport: Transport provided from Woodlands MRT

MOM Licences No: 02C5465

EA Personnel Registration No: R24125030

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon.

As an Quality Engineer you are tasked to ensuring the design transfer and manufacturing operation activities of medical devices produced meet the requirements of Alcon standards, 21 CFR Part 820, Part 11, ISO 13485, the Medical Device Regulation (MDR) and other applicable regulations and standards at Tuas.

In this role, a typical day will include:

• Provide operational support for product release to ensure it meets all quality and regulatory requirements when necessary
• Review and approve validation protocols and reports; ensure compliance with established procedures andsound validation methodology.
• Provide e-compliance oversight to site CSV activities.
• Provide quality oversight to activities related to calibration, preventive maintenance, spare part assessment and associated deviations.
• Support internal and external audits and is responsible for audit finding closure, as required. 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 Identify improvement opportunities and lead/support the implementation activities to improve performance and efficiency.
• Meet quality objectives set by management & comply to Alcon, QMS and Safety requirements.
• Performs any other duties as assigned by Supervisor according to business needs.

What You'll Bring to Alcon

• Bachelor/ Degree in Science, Life Science, Engineering or other appropriate education and
• experience in pharmaceutical and medical device industry
• 1-3 years of experience in Quality Assurance or Quality Control in a Pharmaceutical and
• Medical Device
• Have experience in validation activities.

Why Join Us:

• Opportunity to work with a leading global medical device company.
• Collaborate with a diverse and talented team in a supportive work environment.
• Competitive compensation package and comprehensive benefits.
• Continuous learning and development opportunities.

• Well Established Company
• Basic $6000 - $6500 + Allowance + AWS + Variable Bonus
• Excellent Welfare and Benefits + Career progression
• Working location: West
• Working day: Monday to Friday
• Working hours: 8.30am to 5.30pm
• QMS | ISO 13485 | Medical Devices

Job Responsibilities:

• Conduct assessment and review on supplier qualification, performance and process capability
• Ensure supplier quality issues are deal with, analysed, improved and follow through
• Collect, handle and follow-up on customer feedback/complaints
• Support internal, external and customer audits
• Evaluation, verification and validation of new parts/samples
• Establish and maintain inspection criteria for incoming, in-process and final products
• Identify quality issues, NCR, CAPA handling and drive continuous improvement
• Authorize the release (COC) of products, COA review & approval
• Monthly data analysis on product quality and quality objective
• Review and approval on DHR
• Participate in new projects, commercial product quality management and control
• Drive change management and control
• Other ad hoc duties as assigned

Job Requirements:

• Possess minimum Diploma/Degree in relevant subject area with 2 years’ experience in medical device QA and/or RA
• ISO 13485:2016 certified internal auditor will be advantageous
• Familiar with quality control tools

Candidates are encouraged to apply this position via Apply Now button with the following information in the resume

• Work experiences and job responsibilities
• Current and Expected salary
• Reason for leaving
• Date of availability
• Education background

We regret that only shortlisted candidates will be contacted.

LIONG ZHAO GUAN (R22107632)

EA Recruitment Pte Ltd

EA License No: 21C0492

Your new company

My client (East area) is a global leader in sensory innovation and has established a strong reputation as a trusted supplier of high-quality acoustic components.

Your new role

They're seeking an experienced Quality Management professional to lead their team in ensuring exceptional product quality and driving continuous improvement. As a key member of their leadership team, you will oversee the implementation of their Quality Management System (QMS), including ISO 9001 and ISO 14001 certifications.

Below are some of the key responsibilities for the role;

• Develop and maintain a robust QMS that meets international standards and customer requirements
• Lead and manage a team of quality professionals to ensure effective quality inspection and control
• Collaborate with suppliers to ensure the quality of raw materials and purchased parts
• Drive continuous improvement initiatives to enhance product quality and process efficiency
• Communicate effectively with stakeholders, including customers, suppliers, and internal teams

What you'll need to succeed

The successful candidate, should have;

• Bachelor's Degree in Mechanical or Industrial Engineering
• At least 3 years of quality management experience in the Manufacturing or Machining industry
• Proficient in Office software, Minitab, and Six Sigma methodologies
• Strong knowledge of ISO 9001 and ISO 14001 quality system certifications
• Fluent in English and Mandarin with excellent communication skills, to liaise with stakeholders in China

What you'll get in return

• Joining a company that is at the forefront of our industry
• Being part of a team that's dedicated to innovation and continuous growth
• Working with the latest technologies, tools, and methodologies to develop innovative solutions

What you need to do now

If you believe you meet the specified requirements or know a suitable candidate, please click the link to apply. Alternatively, you may submit your application or referral directly to [email protected].

If this role isn't quite suitable for you, but you're interested in exploring new opportunities, I invite you to contact me for a confidential career consultation. I'm here to help you navigate your next career move.

EA Reg Number: R21102304 | EA License Number: 07C3924 | Company Registration No: 200609504D

Mon to Fri 8.30am - 5.30pm

Job Summary

Responsible for management of Asia Quality System, Policies, Programs and Initiatives. Part of the Global Quality Team to maintain global quality system and drive global initiative.

Role and Responsibilities

Quality Systems

1. Supports overall maintenance of quality systems

2. Monitor and reports on the quality performance for Asia Operations such as product quality performance, supplier performance and gaps for continuous improvement to the management team

3. Maintains the Master control and ISO document control system

4. Maintains customer related documents such as Quality Agreement, PPAP

5. Part of the Global Quality Team, to design and implementation of global policies and systems

Quality Policies

6. Ensures effective implementation of all company quality policies

7. Implements ISO and other recognized standards

8. Implements and monitors statistical techniques such as R&R’s to identify opportunities for improvement.

9. Sets, communicates, and implements quality objectives in line with business goals

10. Manage supplier and customer programs (CCAR, ICAR and SCARs) to ensure that complaints are handled effectively and timely.

11. Support and work with different stakeholders on reporting, monitoring and resolution on customer complaints.

12. Support and work with Supply Chain and Operation on supplier quality issues.

Auditing

13. Leads ISO quality standards implementation as Management Representative.

14. Conducts and leads quality audits to specific quality standards.

15. Leads customer related audits

16. Conducts supplier audits

17. Conducts internal audit investigations for product quality and process issues

18. Responsible for ensuring timely resolution to audit findings

Training

19. Provides training for all employees on basic quality and statistical concepts

20. Provides training to appropriate personnel for updates and changes to quality policy

21. Attends relevant external training sessions/courses and shares learning internally

Job Requirements:

• Degree or equivalent experience in a field of study such as chemistry, business, accounting, engineering, etc.

• Certificate in Quality Engineering is preferred.

• Position requires 3-6 years of quality management experience.

• Good experience into customer & supplier audit and able to conduct training

• ISO 13845 experience will be added advantage.

• Demonstrates introductory understanding and ability and with guidance, applies competency in typical situations.

• Able to design quality systems to meet customer expectations and internal needs. New approaches and continuous improvement must be ongoing

• Good interpersonal skills to be able to communicate and collaborate with all stakeholders and deal with situation proactively

• Junior with 1-2 experience in related field can also apply

• Occasionally overseas travel and weekly conference call is required for the role

• This position required to communicate closely with vendors in China.

Job Description:

• Assist Product Owner, Business Analyst to craft out user story acceptance criteria
• Analyse and decompose complicated software systems, and design a holistic test strategy
• Research emerging technologies and develop test automation framework
• Develop test suites of test scenarios and test cases.
• Perform time-boxed exploratory testing
• Maintain regression test suite in QA nightly build
• Actively refine the smoke test suite in the Development CI environment
• Lead system integration testing with other systems
• Manage user acceptance testing
• Manage defect life cycle, test artifacts, and repository
• Drive continuous improvement in agile testing practices and tools.
• Improve software quality using XP practices such as code review and unit testing
• Understand the IT management policy, quality management policy and security guidelines to ensure the development processes, procedures and system are designed to comply with these policies and guidelines

Job Requirements:

• Degree or Diploma in Computer Science, Computer or Electronics Engineering, Information Technology or related disciplines
• Min 3 years experience in exploratory testing and regression test automation
• Strong analytical skills
• Meticulous attention to details
• Good interpersonal skills
• Experience in agile development environment
• Experience with Robot Framework, SikuliX, Selenium, playwright, Micro Focus Testing Tools (Mobile Center, UFT, QC and Sprinter)
• Certified Software Testing Professional and/or Certified Software Quality Analyst will be an added advantage