Quality Director (Medical Device / USCT)
remotedirector
via Ashby
About this role
WHAT YOU’LL DO
1. Own and evolve the Quality Management System (QMS) to support a regulated medical device development program, including design controls and DHF maintenance.
2. Establish and enforce requirements traceability: user needs → design requirements → verification/validation artifacts and change control.
3. Define and run the program-level V&V strategy (verification, validation, and test coverage), including test plans, protocols, reports, and acceptance criteria.
4. Drive risk management activities (e.g., DFMEA / PFMEA, hazard analyses) and ensure mitigations are reflected in requirements and verification.
5. Lead document control: reviews, approvals, training, retention, and audit readiness.
6.…
What we'd score you on
reqspace match rubricFive dimensions, recruiter-grade. Upload your resume and we'll generate a written explanation of where you fit and where the gaps are.
1
Skills match
We compare your skills against the role requirements.
2
Level fit
This role is director-level. We check your trajectory against it.
3
Domain experience
Your work in the role's domain matters more than your years total. We weight recent and direct experience.
4
Recency
A skill you used last quarter weighs more than one from five years ago. We grade on recency, not lifetime.
5
Location fit
This role is remote-eligible — we factor in your stated location and time-zone overlap.
Score yourself on this role.
Free · no card · written explanation included