Senior Quality Assurance Manager
Posted on :
12-11-2022
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Job Description
Responsibilities:
- The Sr Mgr, Quality Assurance is responsible for supporting the Global Complaint and Health Authority Reporting process team in process mapping, process development, improvement identification, creation and maintenance of procedures. Has understanding of project management and can create professional communication and updates.
- Minimum BS Degree in Engineering or Science related field required.
- Comprehensive knowledge of Quality System standards and regulations including 21 CFR 803 & 820, ISO 13485 / ISO 14971, EU MDR, IVDR
- Five (5+) years or more experience in the medical device industry with knowledge in the area of complaint handling, MDR reporting, Vigilance reporting of medical device or pharmaceutical products.
- Strong written communication skills needed
- Previous management of complaint or health authority teams preferred
- Continuous improvement background preferred
- Project management experience is preferred
Employment Type
Full Time
Key Skills
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