Quality Assurance Specialist

1 month ago


Suzhou, Jiangsu, China Roche Full time

At Roche, we are committed to delivering high-quality medical devices that improve patient outcomes.

About the Role

This is an exciting opportunity to join our team as a Senior Quality Engineer in the Medical Devices sector. As a key member of our quality assurance team, you will play a critical role in ensuring compliance with regulatory requirements and maintaining our company's reputation for excellence.

Job Description

The successful candidate will be responsible for:

  • Managing and coordinating external audits, including China NMPA, TUV/BSI, and US FDA;
  • Driving compliance assessments and mitigation actions development;
  • Preparing and reviewing process documents in accordance with regulatory requirements;
  • Maintaining quality management review processes and preparing inputs for these reviews;
  • Evaluating Q-data to inform corrective and preventive actions;
  • Supporting the development and delivery of quality management-related projects;
  • Sharing expertise and providing support to global teams and other sites as a China GMP expert.

We offer a competitive salary range of $80,000 - $120,000 per annum, depending on experience, plus benefits such as health insurance, retirement plans, and opportunities for professional growth and development.

Requirements:

  • Bachelor's or Master's degree in Life Science, Data Science, or related field; or equivalent experience;
  • At least two (2) years' experience in the Medical Device/Pharma/Biopharmaceutical industry;
  • Experience in managing external audits, China NMPA, TUV/BSI, and US FDA;
  • Familiarity with European, US, China, and international cGMP regulations.

Please note that the salary range provided is an estimate based on industry standards and may vary depending on individual circumstances.



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