Sr. QA Internal Auditor
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.
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 View email address on click.appcast.io learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: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
Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.
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