Offer summary
Qualifications:
B.S. or M.S. in scientific field, 8+ years of quality experience in FDA/ISO regulated environment, Experience in medical device industry, Subject matter expert in diagnostics preferred, Skilled in risk analysis tools.
Key responsabilities:
- Oversee postmarket surveillance and complaint handling
- Develop and maintain postmarket procedures and reports
- Collaborate with regulatory on reporting processes
- Manage investigations and escalations of quality issues
- Engage in continuous improvement activities