• Doc Control Specialist

    Actalent (Irvine, CA)


    Document Control Specialist - Quality Management Systems

     

    Job Type: Long-Term Contract

    Overview:

    We are seeking a highly skilled Quality Management Systems (QMS) Specialist to join our team in Irvine, CA. This role is critical in ensuring compliance with internal policies and external regulatory requirements, including FDA, ISO, EU MDR, and other global standards. The ideal candidate will be instrumental in shaping the future state of our QMS, driving continuous improvement, and supporting cross-functional initiatives across the organization.

    Key Responsibilities:

    + Ensure QMS compliance with internal standards and external regulatory requirements.

    + Lead development and modification of QMS processes to align with business needs.

    + Facilitate Management Review and Quality Planning forums.

    + Identify and implement improvements to enhance QMS efficiency and effectiveness.

    + Support policy and procedure development, maintenance, and optimization.

    + Benchmark best-in-class practices and ensure alignment with industry and regulatory expectations.

    + Manage communications with notified bodies and regulatory agencies.

    + Conduct internal and external audits and support compliance risk assessments.

    + Promote GMP and GDP principles across the Quality organization.

    + Collaborate with cross-functional teams including Product Development, Regulatory Affairs, and Advanced Operations.

    + Participate in QMS-related IS discussions and support system integration and change control processes.

    Required Qualifications:

    + Strong experience in document control and medical device regulations.

    + Proficiency in EU MDR, ISO standards, and CFR requirements.

    + Deep understanding of QMS principles and quality systems.

    + Familiarity with ECOs and ECRs.

    + Experience in the medical device product development lifecycle, including risk management and design/process verification and validation.

    + Knowledge of advanced quality tools such as FMEA, GD&T, Root Cause Analysis, and Poka Yoke.

    + Ability to read and interpret CAD drawings.

    + Proven experience interacting with regulatory bodies (FDA, MoH, TUV).

    + Strong grasp of CAPA, audit processes, and statistical analysis.

    + Project management expertise and ability to work independently.

    + Experience working in a matrixed organization and managing cross-functional projects.

    + Proficiency in MiniTab or similar statistical analysis software.

    Pay and Benefits

    The pay range for this position is $40.00 - $55.00/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 Oct 29, 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.