1 jobs found in Vernon Hills

Job Title: Medical Device Quality and Compliance SpecialistJob Description We are seeking a Medical Device Quality and Compliance Specialist experienced in complaint handling, MDR reportability assessments, post-market surveillance, CAPA support, audit readiness, and risk-based documentation. The ideal candidate will engage in cross-functional collaboration across Quality, Regulatory Affairs, Clinical, R&D, Operations, and business stakeholders. This role requires practical exposure to FDA medical device reporting expectations, 21 CFR Part 803, complaint-handling requirements, quality-system documentation, eMDR/FDA reporting workflows, regulatory decision rationale, and audit-ready records. Responsibilities Handle and assess medical device complaints and MDR reportability. Conduct post-market surveillance activities and support CAPA processes. Ensure audit readiness and maintain risk-based documentation. Collaborate with Quality, Regulatory Affairs,...