9 дней назад
Senior Manager, QARA
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Manager, QARA (Medical Device Quality): Overseeing site quality management, product release, complaint investigations, CAPA processes, and regulatory compliance with an accent on ISO 13485, China NMPA, FDA 21 CFR 820, and quality improvement. Focus on leading quality operations, controlling non-conforming products, supporting audits and recalls, and reducing PPM through cross-functional collaboration.
Location: Beijing, China; approximately 5% overnight travel within the territory and occasional international travel.
Company
partners with customers worldwide to develop science and technology solutions for complex challenges.
What you will do
- Serve as the site Quality Management Representative and oversee daily Quality team operations.
- Ensure incoming material inspection and final product release meet applicable quality standards.
- Monitor product quality, control non-conforming products, and provide training on tools such as 5 Why and Fishbone analysis.
- Lead complaint investigations, adverse event reporting, field corrective actions, recalls, and post-launch product quality improvements.
- Implement and maintain quality management systems and processes aligned with ISO 9001, ISO 13485, China NMPA, and US FDA 21 CFR 820.
- Maintain site KPI reporting, support audits, and drive process improvement and PPM reduction.
Requirements
- Bachelor’s degree in engineering with 9+ years of experience, or a master’s degree with 7+ years of experience.
- Extensive knowledge of medical device quality systems, including China GMP, FDA 21 CFR 820, ISO 14971, and ISO 13485.
- Ability to work in a highly matrixed and geographically diverse business environment.
- Ability to travel approximately 5%, including overnight travel within the territory and occasional international travel.
- Ability to apply business knowledge and collaborate across functions to achieve departmental objectives.
Nice to have
- Experience with IVD quality management systems, post-market processes, or CAPA.
- Medical device industry experience.
- Training or certification in quality or regulatory affairs, such as CQM, CQE, CQA, RAC, Six Sigma, or Lean.
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