Senior Auditor

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

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.

Exact compensation may vary based on several factors, including skills, experience, and education.

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.