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Jobs · Quality Assurance · California

Senior Manager, Quality Engineering

BiVACOR · Huntington Beach, CA · 2 wk ago
On-siteQuality Assurance$155k–$170k/yrFull-time

About the role

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 a second chance at life. If that's the kind of work that gets you out of bed in the morning, we'd love to meet you.

Key Responsibilities

  • Define and execute the strategic vision for the QMS, aligned with ISO 13485, 21 CFR Part 820, 803, and 806

  • Lead and develop a high-performing quality engineering team, providing strategic direction and career development

  • Establish enterprise-wide quality KPIs and present strategic recommendations to executive leadership

  • Direct V&V planning, execution, and documentation for electrical, software, and system-level protocols supporting IDE and PMA submissions

  • Oversee test method validation (TMV) and equipment qualification (IQ/OQ/PQ) programs

  • Own the nonconformance (NC) and QCIR programs, including MRB disposition, root cause investigation, and CAPA linkage

  • Drive systemic resolution of manufacturing quality escapes with root cause rigor

  • Lead FMEA, FTA, and risk management file strategy at the program level per ISO 14971

  • Evaluate field performance data and clinical feedback to identify and mitigate systemic quality risks

  • Architect and lead the end-to-end supplier quality program: qualification, performance monitoring, audits, and corrective actions

  • Conduct strategic on-site audits with focus on high-risk and sole-source AIMD-critical suppliers

  • Partner with engineering and procurement to assess supply chain risk and maintain the approved supplier list (ASL)

  • Serve as the senior quality engineering representative in executive program reviews and manufacturing readiness assessments

  • Lead quality engineering strategy for IDE supplements, PMA modules, and FDA information requests

  • Influence and align R&D, Regulatory Affairs, Software, and Manufacturing Engineering on quality strategy throughout the product lifecycle

  • Define and lead the organizational continuous improvement strategy using Lean, Six Sigma, or equivalent methodologies

  • Sponsor initiatives to reduce defect rates, improve first-pass yield, and optimize QMS processes

What You Bring

  • Bachelor’s degree or higher in Electrical Engineering or similar

  • Minimum 18 years of experience in the medical device industry, including demonstrated senior quality engineering leadership

  • Direct experience with Class III Active Implantable Medical Devices (AIMD), including deep knowledge of FDA IDE/PMA regulatory requirements

  • IPC-A-610 and/or IPC-A-620 certification strongly preferred

  • Technical Expertise: Expert knowledge of IEC 60601 series, ISO 14971, ISO 13485, and 21 CFR Part 820, 803, and 806

  • Deep experience with electrical and electromechanical system qualification for implantable devices

  • Proficiency in FMEA, FTA, statistical analysis, MSA/Gage R&R, and reliability methodology

  • Experience with EO sterilization qualification, cleanroom operations, and QMS software platforms

  • Leadership & Influence: Proven track record of building and inspiring senior quality engineering teams

  • Demonstrated ability to influence executive stakeholders and drive enterprise-level quality strategy

  • Experience representing quality at a senior level in FDA or notified body inspections

  • Track record of leading cross-functional V&V programs for complex regulatory submissions

  • Highly Desirable: VAD or Total Artificial Heart experience, ASQ certification (CQE, CQM/OE, or CRE), familiarity with Enlil, Arena, or comparable QMS/PLM platforms, experience with IDE clinical studies and associated quality system requirements

What We Offer

The expected salary range for this position based in Huntington Beach, California is $155,000 - $169,990. 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.

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