Lab and Med Device Director, Quality Management Manufacturing
About The Position
Castle Biosciences is seeking a Director of Quality Management to lead the development and execution of quality standards across laboratory, clinical, and manufacturing operations, with a primary focus on building scalable, inspection‑ready manufacturing and laboratory quality systems. This role owns the design and continuous improvement of an integrated QMS aligned with FDA, CLIA, CAP, and ISO requirements, partnering closely with manufacturing and laboratory operations leaders to embed quality across production, validation, and product lifecycle activities. This role will be integral to building out the new vertical within Castle's Laboratory and Device Manufacturing Operations.
Requirements
- Bachelor's degree in life sciences or engineering (e.g., Medical Technology, Biology, Chemistry, Biomedical Engineering).
- 10+ years in medical device quality, manufacturing, or product development; startup or early-stage experience a plus.
- 5+ years of demonstrated leadership or management in a regulated environment
- Strategic leadership in clinical and medical device regulatory compliance, with extensive expertise in FDA requirements and ISO standards (13485, 14971, 15189, 14155).
Benefits
- Excellent Annual Salary + 35% Bonus Potential
- 20 Accrued PTO Days Annually + 10 Paid Holidays
- 401K with 100% Company Match up to 6%
- 3 Health Care Plan Options + Company HSA Contribution
- Company Stock Grant Upon Hire
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What This Job Offers
Job Type
Full-time
Career Level
Director
Number of Employees
251-500 employees
