Hybrid Junior QA/RA Specialist in MedTech Growth Job at Cassini Technologies in Staten Island

About the role: We’re looking for aJunior QA/RA Officerwho is eager to learn and grow in a regulated MedTech environment. In thishybrid role, you’ll support our Quality Assurance and Regulatory Affairs teams by maintaining our QMS, supporting regulatory activities, and helping ensure our medical devices meet global regulatory requirements. This is an ideal opportunity for someone early in their career who wants hands‑on exposure toQA, RA, audits, and medical device regulationsin a high‑paced startup setting.

What you’ll do: Manage incoming QA/RA requests and track follow‑up actions Maintain QMS and regulatory databases and document repositories Update procedures, registries, and records Coordinate document reviews and formal sign‑offs Organize and document meetings (Complaints, CAPA, Change Management) Support internal and external audits Support Design History Files and regulatory submissions Assist with global regulatory roadmap activities Support other QA/RA tasks as assigned

What we’re looking for: MBO or HBO degreein Engineering, Law, Science, or a related field Strong organizational skills and attention to detail Comfortable withExcel and PowerPoint Excellent written and verbalEnglishskills Eager to learn, proactive, and positive Able to manage multiple tasks and large amounts of information Passion for quality and doing things right

Nice to have: Exposure toISO 13485, ISO 14971, 21 CFR 820 Experience with medical device registrations in multiple regions International MedTech startup with real clinical impact Strong learning and growth opportunities in QA/RA Open, collaborative, and supportive culture Room to grow as the company scales Candidatesalready residing in the Netherlandsmay be eligible forvisa sponsorship .