• Quality Engineer

    Actalent (San Clemente, CA)


    For immediate consideration, please apply directly to this job posting AND email me at biacosta @actalentservices.com with the following:

     

    1) Word copy of resume

     

    2) 2-3 professional references

    3) 4-5 brief bullet points highlighting technical qualifications

    •Description

     

    We're looking for a Senior or Principal Quality Engineer to join our team. This role is crucial in ensuring that our quality system is top-notch and that our products meet all regulatory and company standards. You'll be working closely with various teams to make sure everything runs smoothly and efficiently.

     

    Product and Process Validation: You'll guide and oversee product and process validations, including sterilization validation and revalidation.

     

    Biocompatibility Studies: Lead studies to ensure our products are biocompatible.

     

    Risk Management: Create and update Risk Management documents as per ISO 14971 for new products or design changes.

     

    Design Control: Represent Quality Assurance on project teams for new or revised products.

     

    Issue Investigation: Investigate any product or production issues and develop corrective actions.

     

    System Maintenance: Oversee and help maintain our Calibration and Preventive Maintenance Systems.

     

    Supplier Management: Evaluate, develop, and monitor suppliers to ensure they meet our standards.

     

    Quality System Support: Support the maintenance of our quality system in compliance with our Quality Policy and regulatory standards.

     

    Regulatory Support: Provide support for regulatory submissions and audits.

     

    Authority on Quality Changes: Have signature authority for changes to manufacturing/quality procedures, processes, and designs.

     

    Training and Direction: Provide training and direction for Quality Inspectors and Technicians.

     

    Skills

     

    Quality assurance, Medical device, risk management, iso 14971, sterilization, biocompatibility, Cleanroom, cardiovascular, audit, design control, process validation, Fda, excel pivot tables, regulatory, regulatory compliance, sterile processing

     

    Top Skills Details

     

    Quality assurance,Medical device,risk management,iso 14971,sterilization

     

    Additional Skills & Qualifications

     

    Experience in biocompatibility a PLUS

     

    Implantable medical device experience

    Experience Level

    Intermediate Level

    Pay and Benefits

    The pay range for this position is $140000.00 - $200000.00/yr.

     

    Internal employee benefits include but are not limited to:MedicalDentalVisionPTO, Holiday CA Sick PayAdditional employee benefit options

     

    Workplace Type

     

    This is a fully onsite position in San Clemente,CA.

     

    Application Deadline

     

    This position is anticipated to close on Oct 22, 2025.

    About Actalent

    Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

     

    The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

     

    If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.