Senior QA Auditor

Senior QA Auditor

This Senior QA Auditor role focuses on planning, executing, and documenting internal and external quality audits, with a strong emphasis on ISO 13485 compliance. The individual will lead audits end to enddeveloping audit plans, conducting on-site and system audits, writing clear and detailed audit reports and findings, and following through on corrective actionswhile also supporting and managing external audits with regulatory bodies such as the FDA and notified bodies. The position requires deep knowledge of quality systems within the medical device or pharmaceutical industry, strong critical thinking and questioning skills to drive process improvement, excellent written and verbal communication, and the ability to work cross-functionally, collaborate effectively, and provide clear updates to management.

Your responsibilities will include:

• Audit Planning & Execution - Develop and execute annual audit plans covering the landscape of the Quality Systems applicable to the division.
• Compliance Monitoring: Ensure adherence to internal policies, external standards, and regulations.
• Evaluate the adequacy and compliance of systems, operations, and practices against regulations and company documentation.
• Assess the effectiveness of internal controls, risk management systems, and identify vulnerabilities in the processes and sub-processes within the Quality Systems.
• Formulate and document nonconformities and obtain concurrence from responsible management.
• Track issues through to closure, including reviewing the corrective actions taken.
• Develop audit plans, including scope and objectives, and obtain management approval.
• Communicate the results of audits to responsible management through the appropriate channels.
• Prepare clear reports on findings, obtain approval, and publish results to the responsible management.
• Oversee the follow-up of corrective actions and audit closure, including escalating overdue items as necessary.
• Participate and support external investigators/auditors from regulatory authorities and notified bodies.

What we're looking for in you:

Required Qualifications:

• Bachelor's degrees at a minimum.
• ISO 13485 Lead Auditor certification is required.
• Minimum of five (5) years of experience in the medical device or pharmaceutical industry, specifically within quality systems.
• Senior-level experience in quality auditing, with the ability to independently plan, execute, and close audits.
• Demonstrated experience conducting internal audits and supporting or managing external audits, including audits with regulatory bodies and notified bodies (e.g., FDA, TV).
• Strong working knowledge of quality systems and ISO 13485 requirements.
• Excellent written communication skills, with experience writing audit reports, findings, and documentation.
• Strong verbal communication and questioning skills, with the ability to critically assess processes and drive improvement.
• Proven ability to work cross-functionally, collaborate effectively with stakeholders, and provide updates to management.

Preferred qualifications:

• Previous Boston Scientific experience
• Proven project management experience