2 jobs found in Libertyville

Job Title: Medical Device Quality and Compliance Specialist Hybrid role! Monday and Friday will work from home and Tuesday, Wednesday and Thursday will be in office. We are looking for people that can virtual interview this week and start next week or the week after! Seeking 1+ year of experience in any of the following areas: complaint handling, MDR reportability assessments, post-market surveillance, CAPA support, audit readiness, risk-based documentation, and cross-functional collaboration across Quality, Regulatory Affairs, Clinical, R&D, Operations, and business stakeholders. Brings 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. Required Strong technical writing, analytical thinking, attention to detail, prioritization, organization, documentation accuracy, project...

Job Title: Medical Device Quality and Compliance Specialist Job 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. 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, Clinical, R&D, Operations, and business stakeholders. Manage quality-system documentation and eMDR/FDA reporting workflows. Provide regulatory decision rationale and maintain audit-ready records. Essential Skills Strong expertise in medical device quality assurance and regulatory compliance. Proficiency in technical writing and corrective action plans. Experience...