Quality Assurance Specialist

Quality Assurance Manager – Medical Devices (Self-Care & Consumer Health)💉Location: North Holland, Netherlands (Hybrid)Company Type: Dutch medical device manufacturer specializing in self-care and consumer health products We are exclusively supporting an innovative, fast-growing medical device organization in identifying a Quality Specialist to join their Quality & Regulatory function. This company develops substance-based medical devices, holds their own IP portfolio, and works with external CDMOs for manufacturing.This position is ideal for someone who enjoys quality documentation, operational execution, and supporting batch release and auditing activities.Key ResponsibilitiesMaintain and prepare technical and regulatory documentation (QMS).Support batch release and ensure records are organized and compliant.Assist with audit preparation (NBs, Competent Authorities, FDA, etc.).Support supplier audits with CDMOs.Maintain quality logs and documentation systems.Contribute to post-market surveillance and regulatory submissions.Help coordinate quality needs around seasonal production cycles.Candidate ProfilePrior experience within Quality in medical devices or pharma.Understanding of MDR; knowledge of Rule 21 is preferred (but not required).Strong document management and organizational skills.Hands-on, proactive attitude; willing to learn.Comfortable in entrepreneurial, lean structures.English proficiency required.Why This Role Is AttractiveGreat development opportunity, working alongside senior experts.Exposure to global regulatory markets across UK, EU, US, Canada, and Australia.Lean business – less bureaucracy, more autonomy.Excellent entry into substance-based medical devices.