• Quality Engineer

    Actalent (Irvine, CA)


    Job Title: Quality Engineer

    Job Description

    We are seeking a diligent and detail-oriented Quality Engineer with expertise in Trackwise to ensure compliance with CAPA processes and procedures. The ideal candidate will be responsible for reviewing and approving non-conformance (NC) and corrective and preventive actions (CAPAs) with a focus on completeness, accuracy, effectiveness, and timeliness. This role involves facilitating and guiding teams through all stages of the NC/CAPA process and maintaining rigorous documentation within the eCAPA system. Additionally, the candidate will play a key role in continuous improvement initiatives and engage in cross-site and corporate projects.

    Responsibilities

    + Ensure compliance with CAPA processes and procedures.

    + Review and approve NC and CAPAs, ensuring completeness of actions and records, accuracy, effectiveness, and timeliness.

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

    + Ensure timely maintenance of a live record with all relevant evidence attached in the eCAPA system.

    + Build expertise in facilitating NC and CAPA teams and promote the use of problem-solving techniques (e.g., human error reduction, 4-D, 5 Why's, fishbone diagrams, process mapping).

    + Serve as a highly proficient eCAPA super-user.

    + Execute the NC/CAPA review board forums.

    + Monitor site NC/CAPA KPIs, including reporting requirements, and provide detailed updates for quality and business review forums.

    + Ensure compliance with global requirements and metrics.

    + Identify continuous improvement and collaboration opportunities.

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

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

    Essential Skills

    + Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.).

    + Ability to gain knowledge and understanding of U.S. and International medical device regulations.

    + Supporting Quality Systems (audits, management review, quality planning, etc.).

    + Strong communication and influencing skills.

    + Ability to manage multiple tasks simultaneously.

    + Strong interpersonal skills.

    + Problem-solving skills.

    + Analytical thinking skills.

    + Ability to work independently.

    + Comfort working in a compliance-risk situation.

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

    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.

    + Proficiency in Trackwise software.

    + In-depth understanding of NCR, CAPA processes, and regulatory requirements for medical devices.

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

    Work Environment

    You will enjoy 2 weeks of PTO and 10 paid holidays. The role involves a collaborative work environment where you will interact with various functional groups and participate in cross-site and corporate projects. The work may involve compliance-risk situations, requiring meticulous attention to detail and adherence to regulatory standards. The position also offers opportunities for continuous improvement and professional development.

    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 May 26, 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.