• Quality Engineer I Trackwise

    Actalent (Irvine, CA)


    Job Title: Quality Engineer I Trackwise

    •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

    Job Description

    We are seeking a dedicated Quality Engineer I with proficiency in Trackwise software to join our team. The successful candidate will play a critical role in ensuring compliance with CAPA processes and procedures within the medical device industry. This position requires a detail-oriented professional with a strong understanding of NCR and CAPA processes.

    Responsibilities

    + Ensure compliance to CAPA processes and procedures.

    + Review and approve NC and CAPAs, ensuring actions and records are complete, accurate, effective, and timely.

    + Liaise with relevant functional groups and guide teams through all stages of the NC/CAPA process.

    + Ensure users maintain a live record with all relevant evidence attached in the eCAPA system.

    + Facilitate NC and CAPA teams in problem-solving techniques such as human error reduction, 4-D, 5 Why's, fishbone diagrams, and process mapping.

    + Serve as an eCAPA super-user, proficient in NC/CAPA procedure requirements.

    + Execute the NC/CAPA review board forums.

    + Monitor site NC/CAPA KPIs, provide detailed updates, and ensure compliance with global requirements and metrics.

    + Identify opportunities for continuous improvement and collaboration.

    + Engage in cross-site and corporate project teams within the NC/CAPA area of expertise.

    + Coordinate preparation, participation, and follow-up for internal, corporate, and third-party audit activities.

    Essential Skills

    + Quality engineering experience within the medical device industry.

    + Proficiency in Trackwise software.

    + Strong analytical and problem-solving skills.

    + Excellent communication and interpersonal skills.

    + In-depth understanding of NCR and CAPA processes.

    + Knowledge of regulatory requirements for medical devices.

     

    Additional Skills & Qualifications

     

    + Bachelor's degree in Engineering, Quality Management, or a related field.

    + Minimum of 1-2 years of experience in quality engineering within the medical device industry.

    + Experience in interacting with regulatory agencies such as FDA, MoH, TUV.

    + Ability to gain knowledge in supporting Quality Systems.

    + ASQ Certified Quality Engineer (CQE) or equivalent preferred.

    + Strong communication and influencing skills.

    + Ability to manage multiple tasks simultaneously.

    + Computer literacy, including Microsoft Word, Excel, and PowerPoint.

    Work Environment

    The role offers a professional work environment with opportunities for growth and development. Employees enjoy benefits such as 2 weeks of PTO and 10 paid holidays. The position involves working in compliance-risk situations and requires comfort in such settings.

     

    Job Type & Location

     

    This is a Contract position based out of Irvine, CA.

    Pay and Benefits

    The pay range for this position is $40.00 - $45.00/hr.

     

    Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

     

    • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

     

    Workplace Type

     

    This is a fully onsite position in Irvine,CA.

     

    Application Deadline

     

    This position is anticipated to close on Nov 27, 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.