Pave Talent
A 26-person medical device company in Gaithersburg, MD is standing up a new manufacturing facility for a drug-eluting biomatrix product. The role is for a hands‑on Director of Quality who has previously built a facility, transferred processes from R&D to manufacturing, and run routine quality operations.
Three Must‑Haves
Facility Startup
– You have brought up a medical device manufacturing facility from scratch, including equipment qualification, facility qualification, and cleanroom validation. You led it, not just participated.
Tech Transfer & Process Qualification
– You have taken a process from R&D to manufacturing, with IQ/OQ/PQ, process validation, and 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, and environmental monitoring. Recent experience, not ten years ago.
What You Will Do
Build quality systems compliant with 21 CFR Part 820 (Medical Devices), ISO 13485, and, where relevant, 21 CFR Part 211 for combination drug‑device products.
Lead facility and equipment qualification for the 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, and 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 are not suitable, as they are subject to different regulatory standards. Contract manufacturing experience alone is insufficient.
Compensation & Location
Base Salary: Extremely competitive.
Equity: Yes.
Work Arrangement: Hybrid, 3 days on‑site in Gaithersburg, MD.
Start Date: Q1 2025.
About the Company This 26‑person medical device company develops drug‑eluting biomatrix products to reduce infection rates in surgical procedures. They have commercialized products with 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.
#J-18808-Ljbffr
Three Must‑Haves
Facility Startup
– You have brought up a medical device manufacturing facility from scratch, including equipment qualification, facility qualification, and cleanroom validation. You led it, not just participated.
Tech Transfer & Process Qualification
– You have taken a process from R&D to manufacturing, with IQ/OQ/PQ, process validation, and 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, and environmental monitoring. Recent experience, not ten years ago.
What You Will Do
Build quality systems compliant with 21 CFR Part 820 (Medical Devices), ISO 13485, and, where relevant, 21 CFR Part 211 for combination drug‑device products.
Lead facility and equipment qualification for the 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, and 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 are not suitable, as they are subject to different regulatory standards. Contract manufacturing experience alone is insufficient.
Compensation & Location
Base Salary: Extremely competitive.
Equity: Yes.
Work Arrangement: Hybrid, 3 days on‑site in Gaithersburg, MD.
Start Date: Q1 2025.
About the Company This 26‑person medical device company develops drug‑eluting biomatrix products to reduce infection rates in surgical procedures. They have commercialized products with 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.
#J-18808-Ljbffr