QA Manager

QA Manager 📍 Location: Amsterdam 🕒 Timing: As soon as possible 💼 40 hours/week

We are looking for a QA Manager to lead quality at Nostics. You will own our quality management system under ISO 13485, the IVDR and FDA 21 CFR Part 820, and build a culture of compliance and continuous improvement. This is a hands-on role for a pragmatic leader with solid IVD experience. You set direction, keep compliance proportionate to a startup, and in the first phase do much of the day-to-day QA work yourself.

As QA Manager, you will: ·     Build, maintain and improve the QMS, including CAPA, nonconformances and change control ·     Act as Management Representative and advise management on quality risks and priorities ·     Run internal and supplier audits and host notified body audits ·     Keep the company audit ready and support regulatory submissions ·     Own our eQMS and use automation and AI tools where they help ·     Report quality KPIs and build the QA team as the company grows

What we’d love you to bring: ·     A Master’s or Bachelor’s degree in life sciences, engineering or a related field ·     5+ years in quality management under ISO 13485, including at least 2 years in IVD under the IVDR ·     Experience hosting notified body audits and supporting CE submissions; FDA experience is a plus ·     Strong knowledge of ISO 13485, IVDR, 21 CFR Part 820 and ISO 14971 ·     Proven leadership: you take ownership and hold colleagues and management to account ·     A pragmatic, hands-on approach and affinity with automation and AI ·     Qualified internal auditor (lead auditor preferred); fluent English, Dutch is an asset

·     A key role in bringing a first-of-its-kind diagnostic to market ·     Ownership, direct access to the management team and room to build the QA team ·     A collaborative, science-driven team ·     Competitive salary, 8% holiday allowance and 30 holidays ·     Collective pension plan and a mobility allowance or free public transport card

Antibiotic resistance is one of the defining health challenges of our time. Our diagnostics help clinicians make faster, better treatment decisions and reduce unnecessary antibiotic use. A strong QMS is what gets this product to patients safely.

At Nostics, we’re building smarter, faster diagnostics for a healthier future. We are developing the world’s first clinical diagnostic platform powered by Surface Enhanced Raman Spectroscopy (SERS), enabling rapid, label-free identification of bacteria directly from patient samples in under 10 minutes. Our first product, DUTI (Direct UTI Identification), targets urinary tract infections: one of the most common primary care presentations and a major driver of inappropriate antibiotic prescribing. We are a growing startup in Amsterdam, now preparing for regulatory submission.