Director of Quality
As the Quality Site Lead, you’ll be the senior-most quality professional on-site — responsible for maintaining and improving our QMS , ensuring ongoing regulatory compliance , and resolving quality issues across internal operations and customer interactions. You’ll work cross-functionally with engineering, operations, and leadership to keep the business inspection-ready, customer-trusted, and focused on continuous improvement.
Duties
- Own and maintain the ISO 13485 QMS , including document control, CAPA, internal audits, and training programs
- Monitor compliance with FDA 21 CFR Part 820 , ISO 13485 , and sterilization standards (e.g., ISO 14937)
- Lead or support investigations, nonconformance reports, and CAPA resolution
- Ensure ongoing inspection readiness and support any external audits or regulatory interactions
- Review and manage equipment release documentation , batch records (as applicable), and quality records
- Serve as the primary point of contact for quality issues , including customer complaints, field issues, or process deviations
- Coordinate internal training and onboarding around QMS procedures and compliance standards
- Collaborate with leadership on risk assessments and quality planning as business needs evolve
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