Senior Quality Assurance Specialist - QMS Compliance
My client is a leading innovator of women's health and is looking for an individual to join their Quality Team to work directly on their diagnostic and treatment equipment. Their portfolio ranges from screening technologies to molecular and cytology diagnostics. They are a large enough company to invest in people and new technology, but small enough to ensure that every single employee can directly impact the business and drive real change for good.
- Leads and/or supports internal and third party (i.e. FDA, notified body, MDDAP, etc.) audits and actions resulting from or associated with audits
- Assists in ensuring QMS is aligned with current applicable regulations and applicable corporate procedures
- Facilitates, leads, and collaborates with cross functional teams for compliant resolutions to nonconformances and other audit findings
- Leads and/or supports gap assessments of the QMS to new and updated guidance, standards, and regulations
- S. in a scientific discipline
- 4-6 years of relevant experience in quality, regulatory, or molecular diagnostics within the medical device industry
- FDA and other regulatory agency interactions
- Advanced knowledge of QSRs, ISO 13485, ISO 14971, MDSAP, and IVDR
- Root Cause Analysis methods and project management
- Auditing experience highly desirable
Competitive benefits on top of a high base salary
If interested, don't wait to apply!!