Director of Quality | Medical Device Facility Startup k

Director of Quality | Medical Device Facility Startup | 510(k) Experience | Relocation Offered

This range is provided by Pave Talent. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$/yr - $/yr

Pave Talent is hiring for a 26-person medical device company in Gaithersburg, MD that is standing up a new manufacturing facility for a drug-eluting surgical/implantable medical device product. They need a Director of Quality who has actually done this before: brought up a facility, transferred processes from R&D to manufacturing, and then run routine quality operations.

This is a hands‑on role. You will personally write SOPs, review batch records, lead CAPAs, and qualify equipment. You will have one direct report (a Principal Quality Engineer), and the team will grow to three people. If you are looking for a strategic oversight position with a large team, this is not it.

The company has a 30% built QMS from a prior facility. You will build the remaining 70% that is facility‑specific and process‑specific. The VP you report to has an operations background, not quality, so they need someone who can own this function independently and make decisions without hand‑holding.

Regulatory Focus: 510(k) & PMA Experience Required

This company is pursuing the 510(k) medical device pathway, not IND/drug submissions. We specifically need candidates with experience in medical device regulatory submissions, not pharmaceutical or biologics backgrounds.

Strongly preferred: Candidates with PMA (Pre-Market Approval) experience for Class III medical devices. While the company's current product may pursue 510(k), PMA experience demonstrates the highest level of medical device regulatory expertise.

Not a fit: Candidates whose primary regulatory experience is IND submissions, GMP for pharmaceuticals, or biologics (BLA). While GMP knowledge is helpful, we need candidates whose core expertise is in medical device quality systems under 21 CFR Part 820.

Three Must-Haves

We will not consider candidates without experience in all three areas:

• Facility Startup – You have brought up a medical device manufacturing facility from scratch. Equipment qualification, facility qualification, cleanroom validation. Not just participated, but led it.
• Tech Transfer & Process Qualification – You have taken a process from R&D to manufacturing. IQ/OQ/PQ, process validation, scale‑up. You know what it takes to get a product from development to commercial production.
• Routine Manufacturing Quality – You have run day‑to‑day quality operations at a manufacturing site. Batch record review, deviations, CAPAs, change controls, lot release, environmental monitoring. Recently, not ten years ago.

What You Will Do

• Build quality systems compliant with 21 CFR Part 820 (Medical Devices) and ISO 13485, with provisions from 21 CFR Part 211 for combination drug‑device products.
• Support 510(k) submissions and prepare quality documentation for FDA clearance.
• Lead facility and equipment qualification for a new manufacturing site.
• Execute process validation, sterilization validation, and packaging qualification.
• Write and review hundreds of SOPs, batch records, and quality system documents.
• Own Design Control activities: DHF, DMR, FMEA, V&V.
• Manage routine quality operations: deviations, CAPAs, change controls, complaints, lot release.
• Serve as the primary contact for FDA inspections and notified body audits.
• Build and lead a small quality team (starting with one, growing to three).

Who You Are

• 10+ years in Quality Management in FDA-regulated medical device environments.
• Deep knowledge of 21 CFR Part 820 (QSR) and ISO 13485.
• Experience with 510(k) submissions; PMA experience strongly preferred.
• Experience at small to mid-size companies (under 250 employees preferred).
• Currently hands‑on with quality operations, not just overseeing others.
• Comfortable making independent decisions in gray areas without escalating.

Ideal Background

Strong Fit:

• Surgical mesh, tissue matrices, drug-eluting devices, implantable medical devices, combination products.
• 510(k) or PMA submission experience.

Not a Fit:

• Pure pharmaceutical backgrounds (IND pathway…