Medical Quality Assurance Specialist

1 week ago


Suzhou, Jiangsu, China 2011 Flextronics Electronics Technology (Suzhou) Co., Ltd. Full time

Position Overview

We are seeking a dedicated Quality Compliance Specialist-Medical to enhance our exceptional teams that develop outstanding products and drive our success.

Reporting directly to the Quality Manager, the Quality Compliance Specialist will be responsible for...

Key Responsibilities:

  • Collaborate with the Regulatory Affairs Manager to design, implement, and uphold an effective quality management system that adheres to medical device regulations (e.g., Good Manufacturing Practices, 21 CFR Part 820) and relevant standards (e.g., YY/T0287/ ISO13485).
  • Assist the Regulatory Affairs Manager in managing quality management system documentation, organizing management review meetings, and preparing necessary materials.
  • Serve as the internal audit coordinator, planning and coordinating internal audit activities for the quality management system in line with applicable regulations and standards.
  • Function as the CAPA engineer/coordinator, ensuring the effective implementation, evaluation, monitoring, and timely closure of corrective and preventive actions.
  • Support the Regulatory Affairs Manager in coordinating audits or inspections from third-party regulatory bodies and assist in customer audit activities.
  • Undertake additional tasks as assigned by management.

Qualifications:

  • Associate degree or higher.
  • Minimum of 3 years of experience in quality engineering or quality management systems within the medical device sector.
  • Experience with PCBA and electronic product assembly processes.
  • Familiarity with medical quality management systems (e.g., YY/T0287/ISO13485) and relevant medical device regulations.
  • Knowledge and capability to understand and execute internal audits of the quality management system.
  • Strong communication, presentation, interpersonal, and organizational skills.
  • Proactive, capable of working independently, and a strong team player.

Benefits:

  • Social Insurance
  • Life Insurance
  • Paid Time Off

Job Category:

Quality

Flex is an Equal Opportunity Employer. Employment selection decisions are based on merit, qualifications, and abilities. We celebrate diversity and do not discriminate based on any protected status.



  • Suzhou, Jiangsu, China Maquet (Suzhou) Co, Ltd. Full time

    About the RoleWe are seeking a highly motivated and experienced Quality Assurance Specialist to join our team at Maquet (Suzhou) Co, Ltd. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our medical devices and processes.Main Responsibilities1. Develop and implement quality control measures to ensure compliance with...


  • Suzhou, Jiangsu, China 2011 Flextronics Electronics Technology (Suzhou) Co., Ltd. Full time

    Position Overview We are seeking a dedicated Quality Compliance Specialist-Medical to enhance our exceptional teams that develop outstanding products and drive our expansion, based in Suzhou Suqian. Reporting directly to the Quality Manager, the Quality Compliance Specialist will be responsible for... Daily Responsibilities Include: ...


  • Suzhou, Jiangsu, China 2011 Flextronics Electronics Technology (Suzhou) Co., Ltd. Full time

    Position Overview We are seeking a dedicated Quality Compliance Specialist-Medical to enhance our exceptional teams that develop outstanding products and drive our expansion. Reporting directly to the Quality Manager, the Quality Compliance Specialist will be responsible for... Daily Responsibilities Include: Assisting the Regulatory Affairs...


  • Suzhou, Jiangsu, China Bosch Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at Bosch. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and processes.Key ResponsibilitiesProcess owner for claims processing in the plant, recording, evaluating, and concluding all claims.Secure short-term delivery...


  • Suzhou, Jiangsu, China SRG Global Full time

    Quality Assurance Specialist **Job Summary** We are seeking a Quality Assurance Specialist to join our team at SRG Global. As a Quality Assurance Specialist, you will be responsible for ensuring the highest quality standards are met in our manufacturing processes. **Key Responsibilities** * Collaborate with customers and suppliers to resolve quality...


  • Suzhou, Jiangsu, China Wärtsilä Full time

    About the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our team at Wärtsilä. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and processes, and for identifying and implementing improvements to our quality management systems.Key ResponsibilitiesConduct regular product...


  • Suzhou, Jiangsu, China Lilly Full time

    Job Title: Quality Assurance SpecialistWe are seeking a highly skilled Quality Assurance Specialist to join our team at Lilly. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality of our products and processes.Key Responsibilities:Provide secondary loop QA support across packaging process teams, including regular...


  • Suzhou, Jiangsu, China Bosch Group Full time

    Job DescriptionWe are seeking a highly skilled Quality Assurance Specialist to join our team at the Bosch Group. As a key member of our quality assurance team, you will be responsible for ensuring the highest quality standards in our production processes.Key Responsibilities:Process owner for claims processing in the plant, recording, evaluating, and...


  • Suzhou, Jiangsu, China Bosch Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at Bosch. As a key member of our production team, you will be responsible for ensuring the highest quality standards are met in our plant.Key ResponsibilitiesProcess owner for claims processing, recording, evaluation, and conclusion of all claims.Secure short-term...


  • Suzhou, Jiangsu, China Bosch Full time

    Job DescriptionAs a Quality Assurance Specialist at Bosch, you will be responsible for ensuring the quality of our products and processes. Your key responsibilities will include:Key ResponsibilitiesProcess owner for claims processing in the plant, recording, evaluating, and concluding all claims.Secure short-term delivery of production in the event of a...


  • Suzhou, Jiangsu, China Maquet (Suzhou) Co, Ltd. Full time

    About the RoleWe are seeking a highly motivated and experienced Quality Assurance Specialist to join our team at Maquet (Suzhou) Co, Ltd. As a key member of our quality team, you will be responsible for leading the part approval process, solving quality issues associated with suppliers, and managing and improving supplier quality performance.Key...


  • Suzhou, Jiangsu, China Lilly Full time

    Job Title: Sterility Assurance Quality Assurance SpecialistWe are seeking a highly skilled Sterility Assurance Quality Assurance Specialist to join our team at Lilly. As a key member of our quality assurance team, you will be responsible for ensuring the sterility assurance program in our Suzhou Parenteral Manufacturing site meets regulatory requirements.Key...


  • Suzhou, Jiangsu, China Maquet (Suzhou) Co, Ltd. Full time

    About the RoleWe are seeking a highly motivated and experienced Quality Assurance Specialist to join our team at Maquet (Suzhou) Co, Ltd. As a key member of our quality team, you will be responsible for leading the part approval process, solving quality issues associated with suppliers, and managing and improving supplier quality performance.Key...


  • Suzhou, Jiangsu, China Danaher Full time

    Quality Assurance ServicesAt Danaher, we are seeking a skilled Quality Assurance professional to provide critical support to our teams. As a Quality Assurance Specialist, you will be responsible for ensuring the highest standards of quality in our products and services.Key Responsibilities:Provide quality assurance services, including external and internal...


  • Suzhou, Jiangsu, China Maquet (Suzhou) Co, Ltd. Full time

    About UsMaquet (Suzhou) Co, Ltd. is a leading medical device company dedicated to providing innovative solutions for healthcare professionals. Our mission is to improve patient outcomes and enhance the quality of life.Job SummaryWe are seeking a highly motivated and experienced Supplier Quality Assurance Specialist to join our team. The successful candidate...


  • Suzhou, Jiangsu, China Bosch Group Full time

    Job Description•As a key member of our team, you will be responsible for ensuring the quality of our products and services. This includes processing claims, evaluating and concluding all claims, and implementing quality assurance measures to prevent future issues.•You will work closely with our production team to ensure that production is delivered on...


  • Suzhou, Jiangsu, China ZF Group Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at ZF Group. As a key member of our quality team, you will be responsible for ensuring the highest quality standards are met in our supplier relationships.Key ResponsibilitiesDevelop and implement advanced quality planning for new projects and engineering changes with...


  • Suzhou, Jiangsu, China Danaher Full time

    Quality Assurance ServicesWe are seeking a skilled Quality Assurance Specialist to provide critical services to ensure the highest quality standards in our organization.Key Responsibilities:Conduct inspection activities to ensure compliance with quality standardsSupport external and internal audits, preparing necessary documents and materialsReview and...


  • Suzhou, Jiangsu, China Danaher Full time

    Quality Assurance ServicesAt Danaher, we are seeking a skilled Quality Assurance Specialist to provide critical services to ensure the highest quality standards in our products and processes.Key Responsibilities:Conduct inspection activities to ensure compliance with quality standardsSupport external and internal audits, preparing necessary documentation and...


  • Suzhou, Jiangsu, China Continental Full time

    Job Title: Customer Quality Assurance SpecialistJob Summary:We are seeking a highly skilled Customer Quality Assurance Specialist to join our team at Continental. As a key member of our quality management team, you will be responsible for promoting a customer-oriented quality culture and ensuring that customer complaints are handled efficiently and...