What are the responsibilities and job description for the Senior Quality Assurance Auditor position at Insight Global?
A client in the medical device industry is seeking a QA Internal Auditor to join their Quality department. This role will own the full audit lifecycle including developing audit plans, conducting internal audits, assisting with external audits, documenting findings and driving corrective actions through to closure. This resource will evaluate quality systems against ISO 13485 and regulatory requirements, identify gaps, and partner with cross-functional teams to improve processes and ensure compliance. They will also support external audits with regulatory bodies, communicate audit results to leadership, and track remediation efforts. This is a full-time permanent position with a hybrid schedule, expected to be onsite 3 days per week in Valencia, CA.
Required Skills & Experience:
• 5 years in medical device or pharmaceutical industry quality systems
• ISO 13485 Lead Auditor certification
• Senior-level experience leading internal audits end-to-end (planning, execution, reporting, closure)
• Experience supporting or managing external audits
• Strong knowledge of ISO 13485 and Quality Management Systems (QMS)
• Proven ability to write clear audit reports and document findings/corrective actions
• Strong cross-functional communication and stakeholder management skills
Nice to Have Skills & Experience:
• Project management experience (PMP is a plus)
• Experience driving process improvements from audit findings
• Exposure to global regulatory environments and multi-site audits
Benefits for this role are provided by the END CLIENT as it is a salaried position paying between $110k-$130k/year bonus benefits.
Salary : $110,000 - $130,000