The Sr. QA Compliance Specialist is responsible for providing subject matter expertise in quality assurance activities such as internal audits, CAPA, External References Control, Complaint Handling, MDR and Vigilance reporting.
Works cross-functionally to ensure maintenance and review of events and complaints, reporting of Medical Device Reports (MDRs), or adverse reaction data, as set forth by the FDA and other regulatory agencies. Requires follow-up internally and externally to assure complete and accurate event files, complaint detail, and product performance information. Supports complaint handling in internal and external audits and inspections
ESSENTIAL DUTIES & RESPONSIBILITES
SKILLS & KNOWLEDGE