Sr. QA Internal Auditor
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At a glance
Requirements
Credentials this posting asks for.
Job overview
Insight Global is hiring a Sr. QA Internal Auditor. The Sr. QA Internal Auditor will manage the entire audit lifecycle, from developing plans to documenting findings and ensuring corrective actions are closed. This role involves evaluating quality systems against ISO 13485 and regulatory requirements, identifying gaps, and collaborating with cross-functional teams to enhance processes and maintain compliance. The auditor will also support external audits and communicate results to leadership.
Key focus areas include Own the full audit lifecycle, Develop audit plans, and Conduct internal audits.
Successful candidates bring 5+ Years Medical Device Or Pharmaceutical Industry Quality Systems Experience, ISO 13485 Lead Auditor Certification, and Senior-level Internal Audits Leading Experience. Important skills include ISO 13485, Quality Management Systems, Audit Report Writing, Document Findings, Document Corrective Actions, and Cross-functional Communication.
Skills & qualifications
Skills
Qualifications
Full job description
Job Description
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.
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to [email protected] learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.
Skills and Requirements
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5+ years in medical device or pharmaceutical industry quality systems
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ISO 13485 Lead Auditor certification
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Senior-level experience leading internal audits end-to-end (planning, execution, reporting, closure)
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Experience supporting or managing external audits
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Strong knowledge of ISO 13485 and Quality Management Systems (QMS)
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Proven ability to write clear audit reports and document findings/corrective actions
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Strong cross-functional communication and stakeholder management skills • Project management experience (PMP is a plus)
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Experience driving process improvements from audit findings
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Exposure to global regulatory environments and multi-site audits
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