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Senior Manager, Quality Assurance and Compliance
2 months ago
This is a senior-level position responsible for ensuring the quality and compliance of medical devices and combination products manufactured by SUN PHARMA. The ideal candidate will have a strong background in quality assurance and compliance, with experience in leading and/or supporting medical device regulatory inspections, corporate audits, and third-party audits.
Key Responsibilities- Quality Management System (QMS) Compliance: Ensure that all medical devices manufactured meet established specifications and are in compliance with corporate requirements and all applicable FDA Part 4, Part 210/211, Part 820, ISO 13485, and Canadian Medical Devices Regulations (CMDR SOR/98-282).
- Regulatory Inspections and Audits: Lead all regulatory inspections related to medical device and combination products (FDA/ISO) and ensure site readiness for regulatory agency inspections and/or corporate audits.
- Device History Records (DHRs): Review and approve DHRs related to medical device products and ensure that they are accurate and complete.
- Vendor/Supplier Management: Oversee the vendor/supplier management program and work closely with vendors/suppliers to develop quality agreements and ensure compliance with regulatory requirements.
- Continuous Improvement: Identify areas for improvement and implement changes to ensure that the QMS is suitable and effective.
- Technical Investigations: Conduct technical investigations related to medical device quality complaints and provide verbal and written responses/resolutions to customers.
- Education: Bachelor's degree in Science or related scientific field.
- Experience: 8-10 years of experience in quality assurance of medical device manufacturing environment.
- Knowledge: Knowledge of medical device regulations, including 21 CFR 4, 21 CFR 210/211, 21 CFR 820, ISO 13485, EU MDR (2017/745), and CMDR (SOR/98-282).
- Skills: Strong leadership and communication skills, with the ability to influence others and work collaboratively in a team structure.
- Office
- Manufacturing Floor
- Warehouse
- Third-Party Site (as required)
- Stand, walk, sit, use hands and fingers to handle or feel, reach with hands and arms, stoop, kneel, crouch or crawl, climb or balance
- Talk or hear
- Close and clear vision
- Computer/office machines
- Lift up to 10 lbs.
- Some travel outside of company facility as required
- Must wear personal safety equipment (gloves, lab coat, gowning, safety glasses)
