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