--- title: 'Senior Quality Systems Auditor at BiVACOR Inc' canonical: 'https://feeny.ai/job/senior-quality-systems-auditor-bivacor-inc-huntington-beach-g7cg2qx412jy' type: 'job' last_seen: '2026-09-13' --- # Senior Quality Systems Auditor at BiVACOR Inc - **Company:** BiVACOR Inc - **Location:** Huntington Beach, CA - **Employment:** full-time - **Work type:** onsite - **Posted:** 2026-04-27 - **Last confirmed live:** 2026-09-13 - **Apply:** https://jobs.ashbyhq.com/bivacor-inc/5268f246-d4d7-4795-a2fd-206b07e5b1f4 ## 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. ## About BiVACOR Inc ## Company Overview - **One-liner**: BiVACOR is a clinical-stage medical device company developing the world’s first titanium Total Artificial Heart (TAH) using magnetic levitation technology to replace both ventricles of a failing heart. - **Entity Type**: Private (Clinical-stage, Series B-III) - **Headquarters**: Huntington Beach, California, USA (with clinical offices in Houston, Texas, and international offices in Gold Coast, Australia) - **Founded**: 2008 - **Founders**: Daniel Timms, PhD (Founder & CTO) ## Core Business - **Primary industry**: Medical Devices / Cardiovascular Therapeutics - **Target customers**: B2B (Hospitals, Cardiac Surgery Centers, Transplant Centers); End-users are patients with end-stage biventricular heart failure awaiting a heart transplant. - **Mission or purpose statement**: "Replacing Hearts. Restoring Lives." The company is committed to addressing the global unmet need of patients with end-stage heart failure by providing a next-generation, long-term life-extending solution. ## Products & Services - **BiVACOR Total Artificial Heart (TAH)**: A clinical-stage, implantable medical device designed to completely replace the function of both ventricles of a failing heart. It is a valveless, electro-mechanical rotary blood pump that uses a single, magnetically levitated (MAGLEV) rotor to pump blood to both the body and the lungs. The device is made of titanium, has no mechanical bearings or flexing diaphragms, and is designed to be compact, durable, and powerful (capable of flows over 12 L/min). It is intended as a bridge-to-transplant for patients with end-stage biventricular heart failure. ## Market Standing - **Valuation/Market Cap**: Not publicly available (Private company). - **Key Metric**: Total funding raised is **$59.75M** (latest round: Series B-III of $9M, raised ~2 years ago). The company is currently conducting an FDA-approved Early Feasibility Study (EFS). - **Notable Investors/Partners**: Key partners include the Texas Heart Institute, Baylor St. Luke’s Medical Center, and St. Vincent’s Hospital Sydney. The company has received funding from various sources including an $18M round to move the TAH through first-in-human studies. The company has a robust collaborative network extending nationally and internationally. - **Growth Signals**: The BiVACOR TAH has been successfully implanted in five patients as part of an FDA Early Feasibility Study (EFS), with all five bridged to a donor heart transplant. The FDA has greenlit an expansion of the EFS to an additional 15 patients. The device was accepted into the FDA’s Total Product Life Cycle (TAP) Advisory Program. The first Australian implantation occurred in November 2024, with the TAH in place for over 100 days. The company received FDA Breakthrough Device Designation. ## Competitive Advantages - **Proprietary MAGLEV Technology**: The BiVACOR TAH uses a single, magnetically levitated rotor with no mechanical bearings, valves, or flexing diaphragms, eliminating mechanical wear and friction. This is a fundamental design innovation compared to traditional volume-displacement TAHs. - **Simple, Durable Design**: The device has only one moving part (the rotor), which is suspended via magnetic levitation. This simplicity is a major differentiator, promising greater long-term durability and reliability. - **Compact and Powerful**: The TAH is designed to fit most men and women (BSA >1.4 m²) and can provide high flows over 12 L/min, sufficient for an adult male during exercise. - **Regulatory Momentum**: The device has received FDA Breakthrough Device Designation, is part of the FDA’s TAP (Total Product Life Cycle Advisory) Program, and has successfully completed a first-in-human Early Feasibility Study (EFS) with all five patients bridged to transplant. The EFS has been expanded to an additional 15 patients. ## Strategic Focus - **Clinical Validation & Regulatory Approval**: The primary focus is on completing the expanded Early Feasibility Study (EFS) and progressing toward a pivotal study and eventual FDA premarket approval (PMA). - **Global Expansion**: Following successful implants in the US and Australia, the company is building a global footprint and clinical evidence base. - **Commercialization Preparation**: With the appointment of a new CEO (Jim Dillon, a veteran medical device executive) and acceptance into the FDA’s TAP program, the company is preparing for eventual commercialization and market entry. ## Why Work Here - **Mission-Driven Work**: Employees directly contribute to a life-saving technology that addresses a critical global unmet need for patients with end-stage heart failure. - **World-Class Team**: Work alongside leading biomedical engineers and renowned cardiac surgeons, including pioneers in the field of artificial hearts. - **Innovative Technology**: Be at the forefront of a paradigm shift in artificial heart design, working with cutting-edge MAGLEV and rotary blood pump technology. - **Culture**: The company emphasizes collaboration, hard work, and recognizing team members. It is described as having a "highly driven and performing team" with a "robust collaborative network." - **Remote/Hybrid/Office Policy**: Not explicitly stated, but the company has multiple physical office locations (Huntington Beach, CA; Houston, TX; Gold Coast, Australia), suggesting an on-site or hybrid model is likely for engineering and lab roles. - **Benefits & Perks**: - **Health**: Medical (HMO/PPO options with fully employer-funded premiums for some plans), Dental, Vision, Short-term & Long-term Disability. - **Time Off**: Generous vacation (80 hours in year one, increasing to 136 hours by year 7) plus an additional 80 hours of PTO per year. - **401(k)**: 4% non-elective employer contribution (immediately vested after 90 days) plus an elective employer match up to 6%. - **Incentives**: Short-term and long-term incentive plans are part of the benefits package. - **Culture**: Described as collaborative, hard-working, and focused on recognizing team members. The company is an equal opportunity employer committed to an inclusive environment. ## Sources 1. [bivacor.com](https://bivacor.com/) 2. [bivacor.com/careers](https://bivacor.com/careers/) 3. [bivacor.com/news](https://bivacor.com/news/) 4. [cbinsights.com](https://www.cbinsights.com/company/bivacor) 5. 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