We place the quality, operations, and engineering leaders who run medical device manufacturing under FDA oversight, ISO 13485 quality systems, and zero-defect expectations.
Medical device manufacturing carries a burden most industries don't: the product can hurt someone, and the FDA is watching. That reality shapes everything — design controls, validation, CAPA, and a quality system that has to hold up to inspection at any moment. The people who run it have to be both operationally sharp and genuinely fluent in regulation.
That dual requirement is the hiring challenge. Plenty of strong operations and quality professionals have never worked under ISO 13485 and FDA QSR, and the ones who have are in high demand. Hiring someone who has to learn the regulatory world on the job is a risk most device makers can't take.
We recruit medical device as a regulated specialty — sourcing quality, operations, and engineering leaders who've lived 13485, FDA, design controls, and validation in a real device environment, including cleanroom and contract manufacturing. You get people who can pass an audit, not just talk about one.
Regulated, mission-driven, zero-defect. We recruit the leaders who deliver compliant quality and reliable operations.
Quality and RA leaders fluent in ISO 13485, FDA QSR, CAPA, and design controls.
Operations and plant leaders who run device manufacturing under regulated conditions.
Design, process, and manufacturing engineers who develop and transfer medical products.
Validation, process, and continuous-improvement engineers who keep production qualified.
Directors and VPs who run device operations on quality, compliance, and delivery.
Has worked under FDA QSR and 13485 in a real device environment — not adjacent regulated industries only.
Real experience with design controls, validation, and a CAPA system that survives inspection.
Has carried a site through FDA inspections and registrar audits cleanly.
Balances zero-defect, compliant manufacturing with actually shipping product on time.
Comfortable with the discipline that cleanroom and validated processes demand.
Medical device pays a premium for regulatory fluency — quality and engineering roles commonly $90K–$150K, operations and quality leadership $150K–$210K+. RA/QA leadership and specialized validation talent command more, and we benchmark to your products and device class.
Yes — genuine 13485 and FDA QSR experience in a real device environment is exactly what we screen for, and we distinguish it from adjacent regulated backgrounds.
Yes — cleanroom operations and Class II and III device manufacturing, including disposables, implantables, and combination products, are core to our device work.
Often 30–75 days given the smaller pool of genuinely regulated talent. We give you a realistic read up front rather than an optimistic one.
Quality and engineering roles commonly $90K–$150K; operations and quality leadership $150K–$210K+, with RA/QA leadership at the top. We benchmark to your products and class.
Yes — RA/QA leadership, quality engineering, operations, and manufacturing/process engineering across the device organization.
Both, though critical regulated leadership roles are often best run retained.
Tell us about your products and your quality system — we'll bring you device professionals who have built and run compliant operations.