QA Engineer, The Hague

About us Cassini Technologies B.V. develops innovative ophthalmic diagnostic solutions, incl. the Cassini Ambient and Cassini Guidance System. We are a CE-marked, FDA-registered manufacturer operating under ISO 13485 and EU MDR. We're growing fast, entering new markets, and building the team to match.

The role We're looking for a QA Engineer to join our Quality&Regulatory team. You'll work hands-on across the full quality lifecycle: QMS maintenance, internal audits, CAPA management, nonconformance handling, and production quality oversight. You report directly to the COO and work day-to-day with our QA Manager. Our QA Manager owns QMS strategy and compliance; you're the engine that keeps it running and improving.

What you'll do

QMS maintenance&continuous improvement• Own day-to-day QMS execution under ISO 13485, EU MDR, and 21 CFR 820; audit-ready at all times • Drive our Quality Transition Plan: update procedures, close documentation gaps, keep revisions on schedule • Maintain document control (DCR processing, version control, timely implementation)• Track and report quality KPIs, incl. setting up measurement infrastructure where it's currently missing • Support eQMS onboarding and ensure records are complete and correctly structured from day one

CAPA&nonconformance• Manage the CAPA system operationally: clear owners, plans, and progress within defined timelines • Support CAPA owners with root cause analysis, planning, and effectiveness verification • Handle nonconforming product identification, segregation, and documentation • Maintain the NC/issuetracker and provide regular management summaries

Audits• Support internal audits per the approved audit program; follow up on findings through to closure • Support preparation for external audits and unannounced inspections

Production quality• Support incoming goods acceptance, pre-release testing, and QC checklist execution • Ensure Device History Records (DHRs) are complete, traceable, and compliant • Identify trends in nonconformances and rework; escalate where action is needed

Training&cross-functional support• Coordinate QMS training for new joiners and updated procedures • Support DHF maintenance and product-related document control across products • Participate in CCB meetings; support change impact assessments • Promote quality awareness and audit-ready behavior across all departments

What we're looking for• HBO or academic background in Engineering, Life Sciences, Biomedical Engineering, or a related field • 2–4 years hands-on QA experience in a medical device environment • Demonstrable experience running CAPA processes, internal audits, and document control; not just supporting them• Working knowledge of ISO 13485:2016; familiarity with EU MDR 2017/745 and/or FDA 21 CFR 820 is a strong plus • Experience with eQMS tools is an advantage • Structured, detail-oriented, and execution-focused - you close what you open • Strong communicator in English; proactive and willing to raise flags early

What you'll find here• A small, highly motivated team building medical technology that makes a real difference in the operating room • A quality function being actively strengthened - you'll help build it, not just maintain a legacy system • Direct visibility: your work influences audit outcomes, product releases, and our compliance posture• Real growth potential as the company scales • A collaborative, international environment across the Netherlands and the US