Senior Quality Systems Auditor

Job description

**Help Us Build the Future of the Human Heart.** At BiVACOR, we're developing the world's most advanced total artificial heart, a technology capable of saving millions of lives around the world. We're a team united by purpose, working on something truly unprecedented. Every process you validate, every fixture you design, and every challenge you overcome plays a direct role in giving patients another shot at life. If that's the kind of work that gets you out of bed in the morning, we think you belong here. **About the Role** We are seeking an experienced QMS Internal Auditor to plan, execute, and report on internal quality system audits in accordance with ISO 13485:2016, 21 CFR Part 820, and FDA IDE requirements. This individual will serve as a key contributor to BiVACOR's ISO 13485 certification readiness program and ongoing QMS surveillance activities, reporting directly to the Director of QA & Regulatory Affairs. **Key Responsibilities: Audit Planning & Execution** - Develop and maintain the annual internal audit schedule based on risk, regulatory requirements, and process criticality. - Lead and conduct internal audits of all QMS processes, including design controls, production & process controls, CAPA, complaint handling, supplier quality, document/record control, sterilization, and clinical device release. - Author audit plans, checklists, and reports in accordance with ISO 13485 and 21 CFR Part 820 requirements. - Coordinate with process owners and subject matter experts to schedule and execute audits with minimal disruption to operations. **Findings Management & CAPA** - Document nonconformities, observations, and opportunities for improvement with clear objective evidence. - Assign and track audit findings through closure, including verification of CAPA effectiveness. - Collaborate with CAPA owners to ensure root cause analyses are thorough and corrective actions are implemented on schedule. **ISO 13485 Certification & Regulatory Support** - Support third-party certification body (CB) audits and surveillance activities, including readiness assessments, escort duties, hosting audits, and CB interface coordination. - Assist with preparation and review of QMS documentation for CB audit submissions. - Provide gap analysis and remediation support against ISO 13485:2016 and 21 CFR Part 820 / Quality System Regulation (QSR). - Support IDE compliance activities under 21 CFR Part 812 as needed, including clinical device release audit trail review. **Audit Program Management** - Maintain the internal audit program, including audit procedure governance, auditor qualification records, and audit metrics reporting to QA leadership. - Track and trend audit findings to identify systemic quality issues and improvement opportunities. - Support training of staff on internal audit methods and quality system requirements. **Travel** - Travel domestically and internationally as required to support multi-site audits, supplier audits, CB audits, or clinical site quality oversight activities (estimated up to 20-30% travel). **What You Bring** - Bachelor's degree in Engineering, Life Sciences, Biomedical Engineering, or a related technical discipline. - Minimum 10 years of experience in Quality Assurance within the medical device industry. - Minimum 5 years of direct internal auditing experience against ISO 13485 and/or 21 CFR Part 820. - Experience with Class III and/or Active Implantable Medical Device (AIMD) development and commercialization strongly preferred. - Demonstrated experience supporting or participating in third-party CB certification audits (ISO 13485). - Familiarity with FDA IDE regulations (21 CFR Part 812) and clinical device release processes preferred. - Thorough working knowledge of ISO 13485:2016 and 21 CFR Part 820 (QSR/QMSR). - Working knowledge of ISO 14971 (risk management), IEC 62304 (software lifecycle), and/or ISO 10993 (biocompatibility) a plus. - Proficiency with electronic QMS platforms (e.g., Enlil, ZenQMS, MasterControl, Veeva, or equivalent). **Certifications (Required — at least one)** - ISO 13485 Lead Auditor certification (e.g., IRCA, Exemplar Global, or equivalent accredited body), OR - ASQ Certified Quality Auditor (CQA), OR - ASQ Certified Quality Engineer (CQE) with documented lead auditor training. **Preferred Qualifications** - Experience auditing sterilization processes (e.g., EO, radiation) and/or sterile medical device manufacturers. - Exposure to Class III AIMD regulatory submissions (PMA, IDE) or design history file (DHF) review. - Experience in a startup or scale-up medical device environment building QMS infrastructure. - Familiarity with supplier quality management and supplier audit execution. - Experience with ISO 13485 certification pursuit from gap assessment through initial certification. **What We Offer** BiVACOR offers a competitive compensation package and comprehensive benefits, including: - 401(k) with company matching - Medical, dental, and vision insurance - Health Savings Account (HSA) & Flexible Spending Account (FSA) - Life insurance & Employee Assistance Program - Generous paid time off The expected salary range for this position based in Huntington Beach California is $126,000 to $138,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Relocation benefits are not available for this posting Apply today and be part of something extraordinary. *BiVACOR is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.*