Quality Director (Medical Device / USCT)
RemoteUnited States only
- Role
- QA
- Experience
- Senior
- Employment
- Full-time
Salary not disclosed
Check eligibility
Open to US only. Set where you work from to check your eligibility.
Optional skills
eQMSGreenlight Guru
WHAT YOU’LL DO
- Own and evolve the Quality Management System (QMS) to support a regulated medical device development program, including design controls and DHF maintenance.
- Establish and enforce requirements traceability: user needs → design requirements → verification/validation artifacts and change control.
- Define and run the program-level V&V strategy (verification, validation, and test coverage), including test plans, protocols, reports, and acceptance criteria.
- Drive risk management activities (e.g., DFMEA / PFMEA, hazard analyses) and ensure mitigations are reflected in requirements and verification.
- Lead document control: reviews, approvals, training, retention, and audit readiness.
- Partner with engineering to make quality “native” to the dev workflow (automated testing, release gates, software configuration management).
- Prepare the program for audits and inspections, including hands-on audit leadership.
WHAT WE’RE LOOKING FOR
- Senior experience leading quality for complex hardware + software products in a regulated environment.
- Deep familiarity with design controls, DHF, document control, risk management, and verification planning.
- Strong systems thinking and the ability to translate ambiguous product intent into testable requirements.
- Comfortable collaborating directly with multidisciplinary engineering (recon/ML, embedded, mechanical, EE, cloud).
USEFUL EXPERIENCE
- Regulated product quality leadership (ISO 13485 / 21 CFR 820 or equivalent), including audit readiness and FDA-facing work.
- eQMS + document control fluency (e.g., Greenlight Guru) that integrates cleanly with modern engineering workflows.
What you'll do
- Own and evolve the Quality Management System (QMS) to support a regulated medical device development program, including design controls and DHF maintenance.
- Establish and enforce requirements traceability: user needs → design requirements → verification/validation artifacts and change control.
- Define and run the program-level V&V strategy (verification, validation, and test coverage), including test plans, protocols, reports, and acceptance criteria.
- Drive risk management activities (e.g., DFMEA / PFMEA, hazard analyses) and ensure mitigations are reflected in requirements and verification.
- Lead document control: reviews, approvals, training, retention, and audit readiness.
- Partner with engineering to make quality “native” to the dev workflow (automated testing, release gates, software configuration management).
- Prepare the program for audits and inspections, including hands-on audit leadership.
What they require
- Senior experience leading quality for complex hardware + software products in a regulated environment.
- Deep familiarity with design controls, DHF, document control, risk management, and verification planning.
- Strong systems thinking and the ability to translate ambiguous product intent into testable requirements.
- Comfortable collaborating directly with multidisciplinary engineering (recon/ML, embedded, mechanical, EE, cloud).
- Regulated product quality leadership (ISO 13485 / 21 CFR 820 or equivalent), including audit readiness and FDA-facing work.
- eQMS + document control fluency (e.g., Greenlight Guru) that integrates cleanly with modern engineering workflows.
Medical Device
Salary not disclosed