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 end—developing audit plans, conducting on-site and system audits, writing clear and detailed audit reports and findings, and following through on corrective actions—while also supporting and managing external audits with regulatory bodies such as the FDA and notified bodies.

Requirements

• Develop and execute annual audit plans covering the landscape of the Quality Systems applicable to the division.
• 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.

Benefits

• Paid time off
• 401k matching
• Retirement plan
• Annual bonus target
• Long-term incentives