Quality Compliance Specialist-Medical

2 weeks ago


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

We are seeking a highly skilled Quality Compliance Specialist-Medical to join our team at 2011 Flextronics Electronics Technology (Suzhou) Co., Ltd. This role will be responsible for ensuring compliance with regulatory requirements for medical devices, including Good Manufacturing Practice for Medical Devices, 21 CFR Part 820, and applicable standards such as YY/T0287/ISO13485.

Key Responsibilities
  • Develop, implement, and maintain an effective quality management system to comply with applicable regulations for medical devices.
  • Manage quality management system documents, organize management review meetings, and prepare related data and files.
  • Plan and coordinate quality management system internal audits in accordance with available regulations and standards for medical devices.
  • Ensure the effective implementation, evaluation, and monitoring of corrective actions and preventive actions.
  • Coordinate audits or inspections from third-party notify bodies and regulatory authorities, and support customer audit activities.
Requirements
  • College or above degree in a relevant field.
  • At least 3 years of working experience in quality engineering or quality management system for medical devices.
  • Experience in PCBA and electronics product assembly process.
  • Familiarity with medical quality management systems and relevant regulations on medical devices.
  • Knowledge and ability to understand and implement internal audits of QMS.
  • Good communication, presentation, interpersonal relationships, and organization skills.
  • Initiative, independent, and good team player.
What We Offer
  • Social Insurance
  • Life Insurance
  • PTO

Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. We celebrate diversity and do not discriminate based on age, race, religion, color, sex, national origin, marital status, sexual orientation, gender identity, veteran status, disability, pregnancy status, or any other status protected by law.



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