Quality Engineer II - Huntington Beach - WorkTrybe

    WorkTrybe
    WorkTrybe Huntington Beach

    1 week ago

    Description
    15th January, 2026
    Manufacturing Quality Engineer II - Process Validation
    • Huntington Beach, CA
    • $91,900 - $99,600 base salary (dependent on experience) + benefits
    • BiVACOR - Replacing Hearts and Restoring Lives.
    Why this role
    • Lead process & equipment validation for a first-of-its-kind Class III medical device
    • Work hands-on in a regulated manufacturing and cleanroom environment
    • Join a mission-driven team developing the world's first long-term Total Artificial Heart
    Our client, BiVACOR is a clinical-stage medical device company developing the BiVACOR Total Artificial Heart (TAH), a revolutionary solution for patients with end-stage heart failure.
    As they scale manufacturing, we are seeking a Manufacturing Quality Engineer II - Process Validation to play a critical role in ensuring their processes, equipment, and test methods meet the highest standards of quality, reliability, and regulatory compliance.
    This is a highly visible, hands-on role working closely with Manufacturing, Engineering, R&D, and Regulatory Affairs.
    What You'll Be Doing Validation Leadership
    • Lead and execute IQ/OQ/PQ for manufacturing and laboratory equipment
    • Develop and manage Process Validation strategies, including PPQ and ongoing process monitoring
    • Perform Test Method Validation (TMV) to ensure accuracy, precision, and reproducibility
    Regulatory & Quality Compliance
    • Ensure compliance with FDA 21 CFR Part 820, ISO 13485, GMP, EU MDR, and related standards
    • Author and review validation documentation including protocols, reports, and SOPs
    • Support internal and external audits, regulatory inspections, and inspection responses
    Manufacturing & Cleanroom Support
    • Provide hands-on quality and validation support in a controlled manufacturing / cleanroom environment
    • Partner with Manufacturing and Engineering to resolve validation gaps and prevent issues at the source
    Risk Management & Continuous Improvement
    • Apply risk-based validation approaches to prioritize activities
    • Lead deviations, nonconformances, investigations, and CAPA
    • Drive process improvements to enhance efficiency, yield, and compliance
    Cross-Functional Leadership
    • Collaborate with Manufacturing, Engineering, R&D, and Regulatory teams
    • Provide technical guidance on quality and validation matters
    • Train and mentor junior engineers on validation best practices
    What We're Looking For
    • Bachelor's degree in Engineering or related discipline
    • 4+ years of experience in Quality / Validation Engineering within medical devices
    • Strong hands-on experience with IQ/OQ/PQ, Process Validation, and TMV
    • Working knowledge of FDA QSR, ISO 13485, GMP, and regulated manufacturing environments
    • Experience supporting manufacturing operations and cleanroom processes
    • Strong problem-solving, documentation, and cross-functional communication skills
    • Someone who can adapt to a start-up environment, collaborate with their direct and wider teams
    Preferred (Nice to Have)
    • ASQ Certified Quality Engineer (CQE) or CSQE
    • Software Validation experience
    • Exposure to automated manufacturing systems, LIMS, or ERP
    • Lean / Six Sigma experience
    • Proficiency with Minitab, JMP, or statistical validation tools
    Why BiVACOR?
    • Work on ground-breaking technology with global, life-saving impact
    • Be part of a high-calibre, collaborative engineering culture
    • Contribute directly to a product advancing toward human clinical studies and manufacturing scale-up
    • Join a company truly living its mission: Replacing Hearts and Restoring Lives
    If you're a manufacturing-focused Quality / Validation Engineer who wants their work to genuinely matter - this is a rare opportunity.

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