Highly Regarded Quality Leadership Position
6 days ago
We are seeking a Senior Quality Manager to oversee our Quality Management System, ensuring compliance with regulatory standards such as ISO 13485 and FDA QSR.
The ideal candidate will possess a strong background in quality systems management for medical devices, with at least 10 years of experience in quality management, particularly with in vitro diagnostics.
Key Responsibilities- Manage QA/QC teams to support all operational functions.
- Oversee the site's Quality Management System (QMS), including CAPA, NCMR, and audits.
- Ensure compliance with regulatory standards such as ISO 13485 and FDA QSR.
- Lead internal and external audits and regulatory inspections.
- Support cross-functional teams in new product development to meet quality requirements.
- Review and approve product changes, ensuring compliance with design control procedures.
- Drive continuous improvement and foster a culture of quality.
Our client is a highly regarded company in the medical and biotechnology industries, known for its innovative contributions and commitment to customer-centric solutions.
As a valued member of our team, you will have access to state-of-the-art technology, a hybrid work schedule, and excellent professional development opportunities.
What We Offer- Competitive compensation package.
- Hybrid work schedule.
- State-of-the-art technology and facilities.
- 401(k) Retirement Plan with employer matching contributions.
- Health Insurance, including medical, dental, and vision coverage.
- Paid Time Off (PTO) and generous vacation, sick leave, and holiday pay.
- Life and Disability Insurance.
- Professional Development Opportunities.
- Wellness Programs.
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