Director of Quality

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:

1. Facility Startup
2. You have brought up a medical device manufacturing facility from scratch. Equipment qualification, facility qualification, cleanroom validation. Not just participated, but led it.
3. Tech Transfer & Process Qualification
4. 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.
5. Routine Manufacturing Quality
6. 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.

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