Quality Assurance Manager
Responsible for setting up the quality assurance system for manufacturing medical devices. The manger will lead the team to get facility certified for ISO13485/ISO14971 compliance, and meet requirement of CE/ FDA for device manufacture.
- Help to build, and administer the QA organization
- Develop QA procedures and standards to support manufacture of medical devices
- Lead efforts in bring the QA system compliant with European and FDA requirement for medical device manufacture
- Assist in draft and review quality documents for regulatory submission, and preparation for regulatory inspections.
- BS degree with a minimal of 6 years experience in medical device industry
- Thorough knowledge of FDA and European quality system requirements including GMP, ISO13485, 14971, Medical Device Directive and applicable quality system standards.
- Ability to analyze and interpret standards, technical procedures, professional journals, government guidance, and regulatory documents.
- Excellent verbal and written communication skills
- Proficiency with MS Office applications
- Demonstrated project management skills and experience
A medical device manufacturer with product ready for launch.
Sat, 15 Jul 2017 13:00:54 PDT