Qvalfocus India
Post Market Quality Assurance Specialist at Qvalfocus India in Remote
ExperiencedRemoteRemote
Skills
FDA 21 CFR Part 803ISO 13485FDA Quality System RegulationEU MDR 2017/745Medical DevicesHealth Hazard AssessmentISO 14971AAMI Standards
Job Description
Hiring a PMQA Remediation Clinical QA Specialist with medical devices to review historical complaints, assess MDR/Vigilance report, submit regulatory reports, support post-market remediation, and ensure FDA, EU MDR, ISO 13485, and QMS compliance.