What are the responsibilities and job description for the Director of Quality - Medical Devices position at Pave Talent?
The Opportunity
A 26-person medical device company in Gaithersburg, MD is standing up a new manufacturing facility for a drug-eluting biomatrix 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 a maximum of 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.
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
- 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 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. Companies like TELA Bio, Integra, Gore Medical, LifeCell, or similar small-to-mid-size medical device manufacturers.
Not a fit: Pure pharmaceutical, biologics, vaccines, gene therapy, or cell therapy backgrounds. These are held to different regulatory standards and candidates tend to over-engineer quality systems for a medical device environment. Contract manufacturing experience alone is also not sufficient.
Compensation & Location
- Base Salary: Extremely competitive
- Bonus: Annual bonus included
- Equity: Yes
- Work Arrangement: Hybrid, 3 days on-site in Gaithersburg, MD
- Relocation: Relocation assistance available for qualified candidates
- Start Date: Q1 2025
About the Company
This is a 26-person medical device company developing drug-eluting biomatrix products that address high infection rates in surgical procedures. They have commercialized products generating revenue, a strong cash position, and are building toward FDA submission for their next-generation product. The culture is fast-paced, collaborative, and mission-driven. They value people who are "contagiously confident, ridiculously relentless, and unanimously united."
How to Apply
This is a confidential search. Apply via LinkedIn and we will contact qualified candidates within 2-3 business days. Interviews are moving quickly with a target start in Q1 2025.
Pave Talent | Hiring Reimagined