Burlington, United States
$120,000 - $140,000
3 months ago
- Actively manage the CAPA process, coordinating cross functional efforts in developing the CAPA plan, corrective actions and effectiveness verifications.
- Manage collaboratively with R&D and Operations for the manufacturing process validation and oversee the equipment IQ/OQ/PQ activities and documentation.
- Assure that the Quality System is in compliance with applicable standards and regulations, including FDA Quality under ISO:13485.
- Coordinate internal and external audit program and oversee the Corrective Action program.
- Responsible to recommend corrective action to the Quality System based upon internal or external quality reports.
- Participate in the Management review duties
- Manage suppliers and OEMs, perform periodic audits abd manage the document change control process.
- Support and coordinate complaint handling, serve as a member of the Quality Review Team to assess adverse events reportability, develop health hazard evaluation and perform US MDR reporting as necessary.
- Develop, refine, and document quality control test and inspection procedures.
- Develop the comprehensive process validation plan that encompass the entire production cycle from raw material receiving to finished product release, including any steps performed at OEM.
- At least 8 years' medical industry experience in an ISO:13485 regulated quality function, including management experience.
- BS in scientific/engineering or relevant discipline
- Thorough understanding of FDA QSR regulations, with a focus n CAPA, complaint handling and process control
- Thorough knowledge of product development process, design controls and a strong command of IQ, OQ, PQ protocols.