Manager, Quality Assurance
- Promote and enhance VB Spine’s quality policy and quality system across the Spine division.
- Provide QA leadership and support throughout the product lifecycle, with a strong focus on new product development, risk management, and design quality engineering.
- Serve as an independent QA reviewer for design control deliverables, DHF/DMR files, custom dossiers, and management review sign-offs.
- Oversee divisional risk management, including defining requirements, establishing procedures, providing training, and ensuring compliance across sites.
- Support sustaining quality activities including validations, calibrations, product transfers, and change controls.
- Act as local QS compliance officer and conduct internal and vendor audits.
- Oversee microbiology and sterility assurance processes within the division.
- Supervise and coach a team of ~8 FTEs plus contractors, providing leadership, mentorship, and clear expectations.
- Provide QA support to prototype and custom shops, tissue bank operations, and divisional complaint handling.
- Continuously improve monitoring, reporting, and metrics for QA and compliance activities.
- Bachelor’s degree required.
- 2+ years of people management experience, with proven ability to lead, coach, and develop teams.
- Strong foundation in risk management, design controls, and design quality engineering.
- Experience in new product development within the medical device industry.
- Knowledge of regulations and standards applicable to spinal implants, instruments, and human tissue products (ISO 13485, 21 CFR 820, 21 CFR 1271, EU MDR, cGMPs).
- Familiarity with Japanese and Canadian regulatory requirements a plus.
- Strong communication skills with the ability to partner effectively across functions (engineering, regulatory, clinical, R&D, and operations).
- High attention to detail, problem-solving mindset, and ability to perform under competing priorities.
- Experience with PLM systems and advanced Microsoft Office/Adobe tools.
- Comprehensive health, dental, and vision insurance
- 401(k) with company match
- Paid time off (PTO) and holidays
- Ongoing training and professional development opportunities
- Opportunity to grow within a fast-paced, dynamic company
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