Sr. Manager / Associate Director, Quality Audits
$165,000–$210,000 year
HybridFremont, California, United States
Job Summary
Establish and oversee the strategic vision for the corporate Internal Audit program and external audit readiness frameworks to ensure compliance with CLIA, CAP, ISO 13485, 21 CFR 820, IVDR, and GCP. Execute the end-to-end audit lifecycle, including master scheduling, resource planning, and formal scoping of complex quality system projects. Author high-level audit reports and present monthly trend reports directly to executive leadership. Lead external regulatory inspections and support preparation for licensure and accreditation assessments. Partner with department heads to evaluate systemic findings and resolve complex compliance issues through root cause analyses. Provide strategic direction and mentorship to internal staff to elevate audit capabilities. Report on-site Monday, Tuesday, and an additional day.
Required Qualifications
- Bachelor's degree in a scientific, engineering, or related discipline
- A minimum of 8–10 years of progressive experience in a Quality Assurance role within an FDA-regulated or ISO-certified medical device, IVD, or clinical laboratory environment
- At least 5 years operating at a senior specialist, project management, or leadership level
- Deep, expert-level knowledge of ISO 13485, 21 CFR 820, ICH E6 (R3) Guidance for GCP, GCLP, CLIA, and CAP regulations
- Proven expertise in quality system methodologies, including CAPA management, Lean principles, 5 Whys, and Pareto Analysis
- Advanced proficiency in data compilation, metric synthesis, corporate SOP authorship, and the use of electronic document management systems (EDMS) alongside standard office suites (Word, Excel, PowerPoint)
- Exceptional written, verbal, and interpersonal communication skills
- A proven track record of leading high-energy, demanding cross-functional initiatives with minimal supervision
- Onsite: Monday, Tuesday, and an additional day
Desired Qualifications
- Advanced degree or professional audit certifications (e.g., ASQ CQA, Lead Auditor certification)
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