Quality Assurance Manager
2 months ago
Regulatory and Quality Solutions LLC (R&Q) is seeking a highly skilled Quality Assurance Manager to join our team. As a Quality Assurance Manager, you will be responsible for developing and improving Quality systems in compliance with requirements through auditing, gap assessment, remediation, and including management and support of Corrective/Preventive actions, Recall, Complaints, etc.
Key Responsibilities:- Develop/contribute to Quality System development: ISO 13485, QSR, MDSAP, 21 CFR 820, GMP
- Improve/remediation Quality systems through development and or revision of elements of the QMS to meet standards or new requirements Usability, ISO 13485:2016, EU MDR, GMP, safety risk management, rd edition
- Write/improve and train others on SOPs
- Perform gap assessments to prepare for external audits/FDA inspections
- Support external audits
- Coordinate and conduct internal audits
- FDA inspection readiness and support
- Conduct EU MDR mock NB audits
- Coordinate and conduct Supplier quality audits
- Select and qualify suppliers
- Create/Maintain Authorize Supplier List (ASL) or scorecards
- Draft Supplier Agreements
- Train others on Supplier Quality
- Develop SOPs for Supplier Quality
- Bachelor's Degree in relevant subject
- Experience working within medical/diagnostic device in a quality role in industry
- Working knowledge of requirements such as 21 CFR 820, ISO 13485 and GMP
- Working knowledge of standards such as: ISO 13485:2016, EU MDR, GMP, safety risk management, rd edition
- FDA Regulatory requirements, the EU Medical Device
- Experience with MDSAP audits
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