Medical Quality Assurance Specialist
2 days ago
Cirtec Medical is a leading provider of manufacturing solutions for complex Class II and III medical devices. Our expertise spans active implants, neuromodulation, interventional cardiology, structural heart, minimally invasive surgical systems, smart orthopedics, and precision components.
Job DescriptionThis role will ensure operational adherence to Cirtec Medical's Quality Management System (QMS) requirements. The ideal candidate will provide input on quality system improvement strategies and approaches.
Key Responsibilities- Corrective/Preventive Actions: Responsible for CAPA administration, tracking individual CAPAs, and performing work on individual CAPAs as necessary.
- Supplier Quality Management: Support Qualification activities and maintenance of the Approved Supplier List (ASL). Support management of Supplier/vendor Corrective Actions (SCAR).
- Internal Auditing: Ensure all internal audits are performed as scheduled. Assess compliance to FDA and ISO 13485 requirements, as well as the internal Quality System.
- Bachelor's Degree required with 0 years of experience, or a combination of education and relevant work experience.
- Quality certification(s) (e.g., ASQ CQT, QCI, etc.).
- Class I, II and/or III Medical Device manufacturing experience.
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