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