Total 164 Manager qa engineer job vacancies in Quality Assurance / Control category in Malaysia

As a part of our team of more than 5000 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards – writing medical history.

We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.

Senior Manager QA (QA Compliance)
The role is responsible for internal audits, external audits and regulatory inspection management and supporting Quality processes. Acts as a check and balance for internal operations, ensures alignment to global quality, internal and general GxP requirements for vendor and material management. Your main responsibilities are:

• Responsible to lead and direct the assigned Quality Process
• Provides QA oversight of the assigned Quality Process to ensure that products are processed, manufactured, stored and distributed according to applicable current GxP and regulations
• Provides QA oversight of the assigned Quality Process to ensure that facilities, equipment, materials, processes and procedures comply with applicable current GxP and regulations
• Implements, maintains and reviews the assigned Quality Process according to applicable current GxP and regulations
• Owns policies and procedures of the assigned Quality Process where applicable.
• Partners with global and communicates to functions to ensure the assigned Quality Process is executed according to established policies and procedures
• Reviews/approves and provides inputs for procedures, documents, records, deviations, investigations, corrective action/preventive actions, change controls and gap assessments associated with the assigned Quality Process
• Ensures deviations from assigned Quality Process are documented and investigated
• Ensures QA personnel are qualified and trained to perform assigned tasks
• Support technology transfer activities.
• Develops strategies for assigned Quality Process to be fit for purpose, site operation readiness, including continuous improvements and ensure a state of inspection readiness
• Leads inspection and audit preparations
• Lead/ coordinates the relevant forums/activities of the assigned Quality process (e.g. Quality Management Review, Quality Risk Review, APQR)
• Escalates quality and compliance risks to Head of Department, QA
• Supports improvement initiatives, programs and projects of the assigned Quality Process
• Build, maintain and develop a team to support the deliverables of this assigned Quality Process

What you have to offer.

• University degree/Advanced Degree in Science (medicine, pharmacy, chemistry, biotechnology, biology or equivalent).
• At least 12 years’ professional working experience in Quality Management System in the pharmaceutical/biotechnology/medical device industry with more than 3 years people management experience.
• Extensive knowledge in Quality Management System concepts and strong understanding of pharmaceutical business and regulatory governance/framework
• Experiences with collaborations with global multidisciplinary functions involved in drug development and manufacturing
• Ability to be agile and effectively collaborate in a dynamic, cross-functional environment
• High degree of conscientiousness and diligence
• Constructive work habits, flexibility, solution orientation, job ownership, quality awareness, and very good planning and organizational skills in a fast-paced environment
• Self-starter and learning capacity
• Sense of ownership and honesty (proactive handling of errors)
• Ability to navigate through ambiguity and rapid growth and adapt to change, especially in a start-up environment
• Expectation to be hands on, interactive and display practical leadership
• Good communication skills
• Fluent in written and verbal English

Benefits for you:

We offer a competitive compensation package which will be determined by the contract type and selected candidate’s qualifications and experience.

How to apply:

Apply now and simply send us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details by using our online form.

Please note:

• Only applications sent via our online form shall be considered.
• Only Candidates with the right qualifications and relevant experience shall be shortlisted and
• Incomplete applications shall be rejected.
• BioNTech will run a background check during the hiring process

We are looking forward receiving your application.

• BioNTech does not differentiate on the basis of gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!

BioNTech - As unique as you

As a part of our team of more than 5.000 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards – writing medical history.

We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.

Senior Manager QA (QA Operations & Release)
This role is responsible and ensures that operations are in alignment and compliant with global Quality, internal and general GxP requirements. Ensures that raw materials are tested meeting specifications and DS, DP are produced meeting the specifications per the dossier and approved appropriately for release.

He/she has a strong commitment to drive a quality mindset culture, safety, health and environment (SHE) compliance for the site.

Your main responsibilities are :

• Lead and direct the assigned Quality Process
• Provides QA oversight of the assigned Quality Process to ensure that products are processed, manufactured, stored and distributed according to applicable current GxP and regulations
• Provides QA oversight of the assigned Quality Process to ensure that facilities, equipment, materials, processes and procedures comply with applicable current GxP and regulations
• Implements, maintains and reviews the assigned Quality Process according to applicable current GxP and regulations
• Owns policies and procedures of the assigned Quality Process where applicable.
• Partners with global and communicates to functions to ensure the assigned Quality Process is executed according to established policies and procedures
• Reviews/approves and provides inputs for procedures, documents, records, deviations, investigations, corrective action/preventive actions, change controls and gap assessments associated with the assigned Quality Process
• Ensures deviations from assigned Quality Process are documented and investigated
• Ensures QA personnel are qualified and trained to perform assigned tasks
• Support technology transfer activities.
• Develops strategies for assigned Quality Process to be fit for purpose, including continuous improvements and ensure a state of inspection readiness
• Supports inspection and audit preparations
• Participates in inspections, audits and Quality Management Review
• Escalates quality and compliance risks to Head of Department, QA
• Supports improvement initiatives, programs and projects of the assigned Quality Process
• Build, maintain and develop a team to support the deliverables of this assigned Quality Process
• Other responsibilities may be assigned by the manager

What you have to offer :

• At least 12 years’ professional working experience in Quality Management System in the pharmaceutical/biotechnology/medical device industry.
• Extensive knowledge in Quality Management System concepts and strong understanding of pharmaceutical business and regulatory governance/framework
• Experiences with collaborations with global multidisciplinary functions involved in drug development and manufacturing
• Ability to be agile and effectively collaborate in a dynamic, cross-functional environment
• High degree of conscientiousness and diligence
• Constructive work habits, flexibility, solution orientation, job ownership, quality awareness, and very good planning and organizational skills in a fast-paced environment
• Self-starter and learning capacity
• Sense of ownership and honesty (proactive handling of errors)
• Ability to navigate through ambiguity and rapid growth and adapt to change, especially in a start-up environment
• Expectation to be hands on, interactive and display practical leadership
• Good communication skills
• Fluent in written and verbal English

Benefits for you:

We offer a competitive compensation package which will be determined by the contract type and selected candidate’s qualifications and experience.

How to apply:

Apply now and simply send us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details by using our online form.

Please note:

• Only applications sent via our online form shall be considered.
• Only Candidates with the right qualifications and relevant experience shall be shortlisted and
• Incomplete applications shall be rejected.
• BioNTech will run a background check during the hiring process

We are looking forward receiving your application.

• BioNTech does not differentiate on the basis of gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!

BioNTech - As unique as you

Job Subject:
Based in the Taren Point area, the site is highly automated, sophisticated and equipped to global best practice. You will assist other sites around Australia with advice on Quality standards and practices. The company has been built on the foundations of culture, workers safety, excellence and process improvements. This ensures that customers product expectations are delivered throughout the companies end to end process. Our client is one of Australia's largest food manufacturers who has been operating and trading for over fifty years, to establish itself as one of the group leader's in the food manufacturing industry. 

About the Role: Responsible for providing planned and daily leadership to the Quality function on site, ensuring safety, quality, culture, capability and the quality aspects of the site.

Reporting directly to the National Quality Manager you will focus on leading 2 people onsite. You will be responsible for

... Click here to view more detail / apply for QA Manager

Purpose of Position:
As the Quality Assurance Manager, you'll play a pivotal role in ensuring the highest standards of quality across the Testing Centre of Excellence (TCoE). Your primary responsibility will be to assist the enhancement and implementation of QA framework, processes, and governance standards. You'll work closely with stakeholders across the organisation, including senior management, to ensure that quality is upheld throughout project lifecycles and BAU activities. ...


Purpose of Position:
As the Quality Assurance Manager, you'll play a pivotal role in ensuring the highest standards of quality across the Testing Centre of Excellence (TCoE). Your primary responsibility will be to assist the enhancement and implementation of QA framework, processes, and governance standards. You'll work closely with stakeholders across the organisation, including senior management, to ensure that quality is upheld throughout project lifecycles and BAU activities.

Key Responsibilities:



... Click here to view more detail / apply for QA Manager ? CoE

• Establishing and implementing the quality standards for products or services

• Monitoring quality testing and identifying gaps in the testing

• Staying current on laws and regulations to ensure compliance

• Overseeing the quality assurance team

• Training other employees on quality procedures

• Handling quality reports and documentation

• Collecting and analyzing quality assurance data

• Working with suppliers to ensure the quality of supplies

Job Scope

• To implement and maintain all quality and food safety control processes complying with the company’s standard, ISO, and local statutory requirements.
• Manage and coach junior QA staff
• To conduct in-house food safety training to production/operation staff.
• To manage customer complaints investigation and perform trouble-shooting and drive process improvement programs to ensure a high standard of food safety and quality.
• Provide technical advice to support other departments when necessary
• Perform QA audits at the central kitchen and outlets and prepares QA reports.
• Monitoring product integrity and conduct product testing for new and regular products.
• To support Operations Director in supplier management program (Audit and ingredient approval).
• Manage external inspection and liaise with regulatory agencies
• Develop recommendations and justifications on Quality Improvement Programs
• To be the primary contact for Government-related agencies’ officials, such as AVA, Muis, NEA, etc.
• Perform ad-hoc duties as assigned by the management.

Requirement

• Diploma or Degree with 3 years of working experience in Quality System.
• Candidates with more experience will be considered for a Assistant Manager role.
• 5.5 working days.
• Only Singaporeans may apply.

Incube8 is a technology company with offices in Singapore (Software Engineers, QAs, DevOps) and United States (Marketing, Product, Data & Analytics, IT, Customer Support). We are seeking an action-oriented, goal-oriented, go-getter QA Manager to lead our QA team in Singapore maintaining exceptional product quality standards for our high performance and scalable applications handling millions of users.

Your main responsibility is to maintain the high product quality standards of our social media web applications. You will lead the QA team and collaborate with the various project development teams and the business to design and implement new and exciting features.

This is an opportunity to join a successful software company offering the chance to work on interesting and varied cross-platform projects using the latest development technologies.

Job Responsibilities:

• Responsible for raising the overall test quality and test maturity of the organization. Focus on refining and standardizing the existing QA framework to facilitate continuous testing across multiple projects.
• Drive and manage software product testing. You will be required to help lay down a strong foundation of quality assurance by:
  • Defining, refining and standardizing QA framework (testing processes and tools) that facilitate continuous testing for all software products/projects.
  • Developing and owning the QA strategy that encompasses both Manual and Automation, ensuring comprehensive test coverage.
  • Identifying and implementing improvements to existing QA methodologies to increase test efficiency and effectiveness. Focus on optimizing both functional and non-functional testing strategies.
  • Review and improve existing testing processes to achieve a balance between manual and automation testing efforts, ensuring that testing is optimized across all team members.
• Define, refine and revise QA metrics and KPIs for the management of QA goals and Management Reporting.
• Analyze defect trends to fine tune QA processes early in the development cycle, minimizing the scale of impact of the defect and the corresponding fixing cost.
• Lead the discussions and determine the appropriate quality initiatives to implement during Sprints with Engineering, Product and other stakeholders.
• Lead hands-on effort to scale-up test coverage using automation, modularise test scripts for reusability and maintainability and tune automation scripts for performance.
• Lead the adoption of new testing tools and technologies that align with industry trends and company goals. Evaluate and integrate to improve testing efficiency and accuracy, ensuring the team stays at the forefront of QA advancements.
• Facilitate and strengthen cross-functional collaboration between the QA team and other teams such as Development and DevOps. Ensure that testing strategies and practices are well integrated throughout the product development lifecycle, improving product quality and stakeholder satisfaction.
• Provide authoritative advice and guidance on any aspect of test planning and execution. Manage the QA team (6 members) daily activities, conducting 1-1s, establish training plans, performance reviews, etc.

Requirements:

• At least 2 years of experience as a QA Manager, leading a team of 4 - 8 QA Manual Testers and QA Automation Engineers, demonstrating strong leadership skills and the ability to foster a collaborative team environment
• At least 10 years experience in the QA industry, with a comprehensive understanding of various QA processes and methodologies.
• At least 6 years of experience in QA Automation, showcasing hands-on experience in both UI and API automation.
• At least 4 years of experience working in a highly scalable, fast paced environment
• Thorough knowledge in Agile QA methodologies, standards and best practices.
• Experienced leveraging Agile QA Testing in an Agile Scrum environment is required.
• Experience with Java for Selenium UI and API Automation is required, demonstrating strong coding skills and understanding of automated testing frameworks.
• Good knowledge of CI/CD pipeline tools such as Jenkins and the integration of Automated Testing tools to them.
• Experience with a variety of testing techniques such as UI Testing, Automated Testing, API Testing, Performance Testing, Smoke Testing, Exploratory Testing, Cross Browser Testing etc.
• Experience with GIT, JIRA, and Confluence is an advantage.
• Advanced ISTQB certification is an advantage.
• Proactive in taking ownership and driving initiatives to completion.
• Enjoys working in a fast-paced, deadline-driven and collaborative environment.

Job description

As a QA/QC Manager cum QMR, your duties and responsibilities include but are not limit to: -

1. Reports to Project Manager and support the Construction Manager

2. Responsible for all Quality Assurance / Quality Control (QA/QC) activities / schedule

3. Review and coordinate all documents / report submissions from subcontractors and/or suppliers

4. Review and issue material and test submissions

5. Coordinate with Client / Consultants / QP(S) on discrepancies on drawings and specifications

6. Make QA/QC plan and update based on work progress

7. Conduct site inspections for all ongoing construction activities and monitor quality of work

8. Conduct site tests

9. Conduct material inspections and monitor delivery

10. Conduct quality assurance audit for South Korea HQ and stakeholders

11. Implement corrective actions for all non-conformances detected

12. Perform other QA/QC-related matters as assigned by Reporting Supervisor

Job Requirements:

Degree in Civil Engineering or related cert

•Minimum 10 year(s) of QA/QC experience in the construction industry, in the quality assurance and Quality control of railways projects of similar scale and complexity.

(Preferably with Singapore LTA project experience)

• At least Bachelor’s Degree in Civil Engineering or equivalent

• Good written and communication skills

• Proficient in Microsoft Office

• Comfortable to work on Saturdays

Other information
Work location at Tuas

To Apply

Please submit your resume in Microsoft Word and indicate the below information:

Current Salary & Expected Salary

Availability to Commence Work

Type of Projects handled.

Working days: 5 days work week
Working hours: 8.30am - 5.30pm
Location: Woodland

Foods Manufacturer

Responsibilities

• Overseeing the operation and whole function of QAQC department
• Establish, review and continuous improvement for Food Safety Management System (SFA Regulations / FSSC 22000 / HALAL / Customers’ requirement) and documentation.
• To lead the QAQC team towards managing, maintaining and food safety management system.
• Review and improve working procedure/criteria for manufacturing processes.
• Overseeing in export country registration, review of importing countries requirement and liaising with regulatory agencies.
• Assisting in laboratory set-up / Overview external lab testing Parameter
• Study the export /import, rule and regulation of the country
• Main point of contact for Government regulatory agencies and certification bodies.
• Any ad-hoc tasks assigned by superior

Chin Wai Loon Reg No: R24121618

The Supreme Hr Advisory Pte Ltd EA No: 14C7279

Working days: 5 days work week
Working hours: 8.30am - 5.30pm
Location: Woodland

Foods Manufacturer

Responsibilities

• Overseeing the operation and whole function of QAQC department
• Establish, review and continuous improvement for Food Safety Management System (SFA Regulations / FSSC 22000 / HALAL / Customers’ requirement) and documentation.
• To lead the QAQC team towards managing, maintaining and food safety management system.
• Review and improve working procedure/criteria for manufacturing processes.
• Overseeing in export country registration, review of importing countries requirement and liaising with regulatory agencies.
• Assisting in laboratory set-up / Overview external lab testing Parameter
• Study the export /import, rule and regulation of the country
• Main point of contact for Government regulatory agencies and certification bodies.
• Any ad-hoc tasks assigned by superior

https://wa.me/6596420989

WhatsApp: +65 9642 0989 (Han)

Email: supreme.cc.han@gmail.com

Chaw Chiaw Han, Reg No：R22106723

The Supreme HR Advisory Pte Ltd, EA No：14c7279

The APAC Quality Manager maintains and optimizes the quality management system for the Asia Pacific region in support of commercial and logistics operations. This role will assess regulatory and business requirements and drive continuous improvement activities, ensuring the QMS fulfills both regulatory and customer requirements. In addition, the incumbent will also be responsible for the following:

• The complaint handling system for both regulated and non-regulated products based on the global complaint handling process.
• Represent the QMS as the Quality Management Representative per ISO requirements
• Serves as the primary point of contact for Notified Body audits and regulatory agency inspections
• Maintains and improves the site document management control, CAPA, internal audit, and supplier audit processes
• Supports the Quality Notification, Global Field Safety Notification & Ship Hold processes
• Organizes and conducts quality-related training to internal employees and distributors
• Maintains the Singapore controlled drug and poison licenses for the import and release of controlled drug products in Singapore.
• Supports Veterinary certificates or other government agency licenses activities for the Asia Pacific distribution center operation
• Manages the secondary assembly program at the Singapore Distribution Center

How You’ll Make an Impact:

• Ensures the QMS for Asia Pacific region is effective and aligned with the Complany Quality Policy and quality objectives, fulfills both regulatory and customer requirements
• Supports the commercial organization for the supplier audit program.
• Maintains controlled drug licenses and execute operation control on the release of controlled drug products.
• Support export documentation such as coordinating of the Veterinary certificate and poison licenses to support distribution center operation.
• Supports Australia, New Zealand and Korea import permit activities
• Assess and resolve gaps between regulations and the quality management system
• Maintains, optimizes, and improves current complaint handling system based on global complaint handling policy
• Responsible for post-market actions based on divisions’ CAPA plan and local regulation requirements. Support Quality Notification, Global Field Safety Notification & Ship Hold
• Be responsible for managing local SOPs according to Global SOPs. Maintain document control process
• Organize internal and external audits of the quality management system

What You Bring:

• Bachelor degree in Pharmacy. Professional pharmacist or intermediate certificate of clinical examination is preferred. Pharmacist registered with the Singapore Pharmacy Council
• At least 7 years' work experience in QA with 3 years management experience.
• Strong planning/organization skills
• Personnel management skills
• Good spoken and written English ability
• Strong ability to work effectively with diverse responsibilities
• Excellent interpersonal communication skills
• SAP ERP experience is a plus

Who We Are: For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Recently voted a Best Place to Work, Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see.

Benefits: Bio-Rad's biggest asset is our people, and this is the reason why our Total Rewards deliver programs that provide value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Our offerings serve to enrich the overall health, wealth, and wellbeing of our employees and their families through the various stages of an employee’s work and life cycle. We’re proud to offer comprehensive medical plans and insurance, wellness programs, extensive learning and development opportunities and more.

EEO Statement: Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with disabilities, and people of all races, ethnicities, genders, ages, and orientations are encouraged to apply.

Agency Non-Solicitation: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.

#LI-GT1

Interested candidates, please submit your application through the Bio-Rad Careers website:

https://careers.bio-rad.com/jobs/quality-mgr-asia-pacific-singapore

• Well Established Company
• Basic $6800 - $8000 + 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

Job Responsibilities:

• Maintain the Quality Management System to ensure compliance with ISO 13485:2016 requirements, applicable international standard/regulation requirements, and customer requirements
• Identify the gap in the QMS and make continuous improvements to ensure the effectiveness of QMS implementation and consistency with product and process requirements. Lead the training on procedures and practices to QMS requirements
• Lead the internal audit and customer audit, follow-up on audit non-conformance activities till closure
• Responsible for major customer projects and quality deliveries, handling product quality issues, and responding to major customer complaints and quality improvement
• Authorize the release of major customer products
• Manage and verify CAPA, NCR, SCAR handling, root cause analysis, and action taken
• Risk management, validation and verification activities
• Provide the necessary training, such as QMS, supplier management, design control, MSA, G R&G, 8D etc.
• Support on monthly quality objective and KPI review
• Support on Quality Management Review
• Any other duties as assigned from time to time

Job Requirements:

• Bachelor’s Degree with minimum 5 years of experience in quality management/ assurance and/or risk assessment in medical device industry
• Qualified lead auditor or ISO 13485:2016 internal auditor, be familiar with ISO 14971:2019, Cleanroom, and applicable regulatory and standards

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

• Well Established Company
• Basic $6500 - $8000 + 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

Job Responsibilities:

• Maintain the Quality Management System to ensure compliance with ISO 13485:2016 requirements, applicable international standard/regulation requirements, and customer requirements
• Identify the gap in the QMS and make continuous improvements to ensure the effectiveness of QMS implementation and consistency with product and process requirements. Lead the training on procedures and practices to QMS requirements
• Lead the internal audit and customer audit, follow-up on audit non-conformance activities till closure
• Responsible for major customer projects and quality deliveries, handling product quality issues, and responding to major customer complaints and quality improvement
• Authorize the release of major customer products
• Manage and verify CAPA, NCR, SCAR handling, root cause analysis, and action taken
• Risk management, validation and verification activities
• Provide the necessary training, such as QMS, supplier management, design control, MSA, G R&G, 8D etc.
• Support on monthly quality objective and KPI review
• Support on Quality Management Review
• Any other duties as assigned from time to time

Job Requirements:

• Bachelor’s Degree with minimum 5 years of experience in quality management/ assurance and/or risk assessment in medical device industry
• Qualified lead auditor or ISO 13485:2016 internal auditor, be familiar with ISO 14971:2019, Cleanroom, and applicable regulatory and standards

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

• Reporting to General Manager and oversee the daily quality activities including involvement in new project development relating to technical and non-technical operations

• Lead and drive the team for continuous improvement on system and process.

• Work as quality representative of tool room to manage customer audit, ISO audit and internal audit, prepare the team for the audit and subsequent activities.

• Monitor KPI of tool room and attend annual MR meeting to report tool room KPI performance.

• Lead QA/metrology team for inspection activities and work closely with engineering team for tool improvement.

• Manage customer complaint and attend customer meeting related to quality or metrology issues.

• Monitor supplier quality performance and issue corrective and preventive action report to drive continuous improvements.

• Perform audits on supplier’s process to ensure quality control and quality assurance systems are in place

• Publish tool fabrication quality standards and ensure suppliers understood and comply with the requirements

• Assist in evaluation and qualification of new supplier.

Requirements:

• Diploma/ Degree in Quality Engineering or related fields

• At least 5 to 7 years of relevant experience in quality management systems in a manufacturing environment. Experiences in plastics/mold making industry advantageous

• Knowledge and experience in GD&T, SQC tool and ISO 9001, ISO 14000 & ISO 13485 QMS

• Good verbal and written communication skills

• Organized, decisive, independent leader

• Office: Joo Koon/Boon Lay | Mon – Fri (8:30am to 5:45pm)

• Monthly salary x 13 + Variable Bonus. Monthly salary will commensurate according to experiences

• Candidates who can start immediately or short notice preferred

We invite interested and qualified candidates to send in your updated resume (MS Word Format), stating your reasons for leaving each employment, your current and expected salary to theresa@personnellink.com.sg and cc Career@personnellink.com.sg. Please indicate the position you are applying in your email subject. Your interest will be treated with strict confidentiality,

We regret to inform that only shortlisted candidates will be notified

EA License: 90C3627

EA Reg No: R1108020

• Well Established Company
• Basic $7000 - $8000 + 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

Job Responsibilities:

• Maintain the Quality Management System to ensure compliance with ISO 13485:2016 requirements, applicable international standard/regulation requirements, and customer requirements
• Identify the gap in the QMS and make continuous improvements to ensure the effectiveness of QMS implementation and consistency with product and process requirements. Lead the training on procedures and practices to QMS requirements
• Lead the internal audit and customer audit, follow-up on audit non-conformance activities till closure
• Responsible for major customer projects and quality deliveries, handling product quality issues, and responding to major customer complaints and quality improvement
• Authorize the release of major customer products
• Manage and verify CAPA, NCR, SCAR handling, root cause analysis, and action taken
• Risk management, validation and verification activities
• Provide the necessary training, such as QMS, supplier management, design control, MSA, G R&G, 8D etc.
• Support on monthly quality objective and KPI review
• Support on Quality Management Review
• Any other duties as assigned from time to time

Job Requirements:

• Bachelor’s Degree with minimum 5 years of experience in quality management/ assurance and/or risk assessment in medical device industry
• Qualified lead auditor or ISO 13485:2016 internal auditor, be familiar with ISO 14971:2019, Cleanroom, and applicable regulatory and standards

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