Director of Quality | Medical Device Facility Startup k

You’ve built quality systems before. You know what it takes to bring a manufacturing facility from an empty shell to a functioning, FDA‑compliant operation. You’ve led tech transfers, qualified equipment, and written the SOPs yourself rather than reviewing someone else’s drafts.

Now imagine doing it at a company where your work directly reduces infection rates for breast cancer patients, where the technology is already proven, and where you won’t spend six months getting approval to move forward.

Pave Talent is hiring on behalf of our client, a publicly traded medical device company in Gaithersburg, MD that develops drug‑eluting biomatrix products for surgical applications. This is a small, focused team of highly credentialed professionals, recently certified as a Great Place to Work, with a median tenure of over six years. The company recently completed a major asset sale of their cardiac business to a Fortune 500 medical device company, fully funding their next‑generation product development with zero debt.

They have commercialized products generating revenue and a clear regulatory pathway ahead.

This isn’t a maintenance role. You’re building the quality function for a new manufacturing facility from the ground up. The QMS is roughly 30% built from a prior product line. You own the remaining 70%. You’ll report to a VP with an operations background, not quality, which means you will be the quality expert in the room. There are no layers between you and executive leadership, and the decisions you make will directly shape how this company manufactures and commercializes its products.

At a larger company, this kind of scope and visibility takes a decade to earn. Here, it’s day one.

The CEO is a recognized expert in regenerative medicine who has led organizations generating more than $1 billion in shareholder value. The Chief Scientific Officer has brought products to market responsible for over $1.5 billion in sales. Over half the team holds advanced degrees, and one‑third hold doctorates. Women hold 62% of leadership positions. This is a team of A‑players who debate hard, align fast, and move.

The company’s drug‑eluting biomatrix platform has already been validated by the market. Their first product reduced cardiac device infection rates dramatically and was acquired by a Fortune 500 company. Now they’re applying the same proven technology to breast reconstruction, where infection rates of 15 to 20% remain a serious clinical problem. The target market is $1.5 billion in the U.S. alone.

This isn’t speculative. The technology works. The regulatory pathway is medical device (510(k)), not pharmaceutical. The development program is fully funded through commercialization without shareholder dilution.

You’re good at what you do. But if you’re honest, you’re maintaining a quality system someone else built, or you’re managing a team that does the hands‑on work while you sit in meetings. The last time you personally wrote an SOP or led a CAPA was longer ago than you’d like to admit.

Here’s the alternative: own a quality function at a company where the product saves patients from repeat surgeries, where you build the systems your way, and where you’ll interact directly with the CEO and CSO on a regular basis. You’ll get compressed career experience in facility startup, tech transfer, and commercial manufacturing quality in a timeline that would take years at a bigger company.

If you’ve been waiting for the right small‑company opportunity, this is worth a conversation.

You’ll report to the VP of Operations and serve as the company’s quality leader. You’ll start with one direct report (a Principal Quality Engineer) and build the team to three. You’ll work closely with R&D, Regulatory Affairs, and Operations at the Gaithersburg facility, with regular interaction with executive leadership based in San Diego.

• Build the remaining 70% of the quality management system, compliant with 21 CFR Part 820 and ISO 13485, with provisions from 21 CFR Part 211 for combination drug‑device products.
• Lead facility qualification, equipment qualification, and cleanroom validation for a new manufacturing site.
• Execute…