Senior QA Auditor
Core
Planning, executing, and documenting internal and external quality audits with a strong emphasis on ISO 13485 compliance for medical device or pharmaceutical quality systems.
Role type
Senior QA Auditor
Builds
Compliance assurance and process improvement within Quality Systems
Domain
Medical device / Pharmaceutical / Quality Systems
Deliverable
client delivery
Required skills
ISO 13485 Lead Auditor certification, audit planning and execution, regulatory compliance knowledge (FDA/notified bodies), corrective action tracking, risk management assessment, nonconformity documentation, cross-functional collaboration
Preferred skills
Project management experience
Technologies
ISO 13485, FDA regulations
Responsibilities
Develop and execute annual audit plans covering the Quality Systems landscape; Ensure adherence to internal policies, external standards, and regulations; Evaluate the adequacy and compliance of systems, operations, and practices against regulations; Assess the effectiveness of internal controls and risk management systems; Formulate and document nonconformities and obtain management concurrence; Track issues through to closure including reviewing corrective actions; Prepare clear reports on findings and publish results to management; Oversee the follow-up of corrective actions and audit closure; Participate and support external investigators/auditors from regulatory authorities.
Seniority
Senior, hands-on IC