Supplier Quality Engineer - Irvine - Intellectt Inc

    Intellectt Inc
    Intellectt Inc Irvine

    2 days ago

    $80,000 - $135,000 (USD) per year * Pharmaceutical / Bio-tech
    Description

    Supplier Quality Engineer II (Onsite – 80%+) in Irvine, CA

    Travel: Up to 25% (domestic & international)

    Position Overview

    The Supplier Quality Engineer II will support design and development teams in qualifying critical materials and suppliers for innovative, life-saving medical devices. This role ensures supplier compliance with internal and regulatory requirements while collaborating cross-functionally with R&D, Operations, Quality, Sourcing, and Regulatory Affairs.

    Key Responsibilities

    • Qualify and manage suppliers for OEM/custom materials and components
    • Ensure compliance with FDA and global regulatory standards
    • Support supplier audits, validation, and risk management activities
    • Develop and validate inspection/test methods for incoming quality
    • Drive root cause investigations (NCR, CAPA, SCAR) and corrective actions
    • Support Design Development File and design control requirements
    • Apply statistical and quality engineering tools (dFMEA, Gage R&R, RCA)

    Required Qualifications

    • Bachelor's degree in Engineering or related Scientific field
    • 2+ years of experience in Supplier Quality, Manufacturing, or Quality Engineering
    • Experience in a highly regulated industry (Medical Device preferred)

    Preferred Qualifications

    • Experience with Class II or Class III medical devices
    • Knowledge of FDA & international medical device regulations
    • Experience conducting supplier/vendor audits
    • Strong problem-solving and statistical analysis skills
    • Six Sigma/Lean or ASQ certification (CQE/CQA) preferred
    * This salary range is an estimation made by beBee
  • Work in company

    Quality Engineer

    Only for registered members

    We are looking for a Design Assurance / Quality Engineer who will collaborate with a cross-functional design team to develop novel cardiovascular devices/therapies.We require experience in medical device manufacturing and early product development phases. · ...

    Irvine, CA

    1 month ago

  • Work in company

    Quality Engineer

    Only for registered members

    We are hiring Quality Engineers of varying experience levels to join our team Quality Engineers play a critical role in ensuring products processes and systems meet internal quality standards and applicable regulatory requirements within a regulated biotechnology environment. · - ...

    Irvine, CA

    1 week ago

  • Work in company

    Quality Engineer

    Only for registered members

    + Develop and maintain robust quality systems to ensure products meet internal quality standards and regulatory requirements within a regulated biotech environment. Monitor manufacturing performance to proactively identify quality risks. Lead root cause investigations related to ...

    Irvine

    1 week ago

  • Work in company

    Quality Engineer

    Only for registered members

    We are looking for a Quality Engineer (Medical Devices) to work closely with our R&D and Manufacturing teams to develop the latest tools and technologies to address significant, unmet clinical needs that impact patients' lives around the world. · Identify and solve complex proble ...

    Irvine, CA

    2 weeks ago

  • Work in company

    Quality Engineer

    Only for registered members

    Innovation starts with patients. As a Quality Engineer, you'll partner with R&D and Manufacturing teams to develop and improve medical device processes, · Lead quality engineering activities across R&D and Manufacturing in a regulated environment · Drive QMS improvements, documen ...

    Irvine, CA

    2 weeks ago

  • Work in company

    Quality Engineer

    Only for registered members

    A Quality Engineer will collaborate with a cross-functional design team to develop novel cardiovascular devices/therapies. · Collaborate with R&D teams in design engineering risk management design controls test method development process development quality assurance regulatory c ...

    Irvine, CA

    2 weeks ago

  • Work in company

    Quality Engineer

    Only for registered members

    Supervises, supports and implements the activities of the Shur-Lok Quality Assurance System. Administers those activities that are designed to meet customer requirements for a Quality Assurance System. · ...

    Irvine, CA

    1 week ago

  • Work in company

    Quality Engineer

    Only for registered members

    We are seeking a detail-oriented and experienced Quality Engineer to join our team. · ...

    Irvine, CA

    1 month ago

  • Work in company

    Quality Engineer

    Only for registered members

    The Quality Engineer is responsible for maintaining quality and control of manufacturing processes and post-market performance of medical devices. · ...

    Irvine, CA

    2 weeks ago

  • Work in company

    Quality Engineer

    Only for registered members

    We are looking for a Quality Engineer (Design Control/Risk Management) who will collaborate with a cross-functional design team to develop novel cardiovascular devices/therapies. · In-depth knowledge of Design Control, Risk Management , and related standards. · Knowledge of Quali ...

    Irvine, CA

    1 month ago

  • Work in company

    Quality Engineer

    Only for registered members

    Quality Engineering is responsible for product and service quality evaluation and control Works cross-functionally in the development and or maintenance of products or servicesThe Engineer is involved in resolving the equipment and process-related production issues activities inc ...

    Irvine, CA

    1 month ago

  • Work in company

    Quality Engineer

    Only for registered members

    The Quality Engineer will manage high reliability military/defense aerospace, medical and commercial contractors and associated supply chains. · Manage various assigned programs for quality compliance to all aspects of customer contracts. · Selecting manufacturing equipment inclu ...

    Irvine, CA

    1 month ago

  • Work in company

    Quality Engineer

    Only for registered members

    Innovation starts from the heart. At client, we put patients first. We invest a significant proportion of our revenue towards research and development to drive and develop groundbreaking medical innovations for structural heart disease and critical care. · ...

    Irvine, CA

    1 month ago

  • Work in company

    Quality Engineer

    Only for registered members

    For immediate consideration, please apply directly to this job posting AND email me at biacosta with the following: · word copy of resume · 2-3 professional references · 4-5 brief bullet points highlighting technical qualifications Job Title: Quality Engineer - NPI · Job Descrip ...

    Irvine, CA $80,000 - $145,000 (USD) per year

    4 days ago

  • Work in company

    Quality Engineer

    Only for registered members

    The Quality Engineer plays a pivotal role in risk management and efficacy of medical devices focusing on kidney disease. · Lead post-market surveillance programs to monitor product performance and safety trends. · Collaborate with R&D teams to drive corrective actions. · ...

    Irvine, CA

    1 month ago

  • Work in company

    Quality Engineer

    Only for registered members

    PSC Biotech is hiring Quality Engineers to join its team in ensuring products meet quality standards and regulatory requirements within a regulated biotechnology environment. · ...

    Irvine, CA

    1 week ago

  • Work in company

    Quality Engineer

    Only for registered members

    PSC Biotech is hiring Quality Engineers to ensure products meet internal quality standards and applicable regulatory requirements within a regulated biotechnology environment. · ...

    Irvine, California, United States

    1 week ago

  • Work in company

    Quality Engineer

    Only for registered members

    This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. · ...

    Irvine, CA

    1 month ago

  • Work in company

    Quality Engineer

    Only for registered members

    Innovation starts with patients. As a Quality Engineer you'll partner with R&D and Manufacturing teams to develop and improve medical device processes ensuring quality compliance and patient safety while supporting next-generation technologies. · ...

    Irvine

    3 weeks ago

  • Work in company

    Quality Engineer

    Only for registered members

    As a Quality Engineer specializing in New Product Introduction (NPI), you will advocate and lead design for manufacture and assembly through technical leadership in quality assurance and control. · ...

    Irvine $80,000 - $145,000 (USD) per year

    5 days ago

  • Work in company

    Quality Engineer

    Only for registered members

    Perform Quality Engineering activities related to product development and ongoing cleanroom build support. · ...

    Irvine

    1 month ago

Jobs
>
Supplier quality engineer
>
Jobs for Supplier quality engineer in Irvine