• Quality Manager

    Actalent (Longmont, CO)


    Job Title: Quality Manager

    Job Description

    We are seeking a dedicated Quality Manager to develop and maintain a quality management system that complies with ISO:2016 and FDA regulations. The successful candidate will be responsible for conducting internal and external quality audits, managing supplier quality systems, and leading and developing the quality team.

    Responsibilities

    + Develop and implement a quality management system in compliance with ISO:2016 and FDA regulations.

    + Conduct internal and external quality audits to ensure adherence to regulatory standards.

    + Manage and oversee supplier quality systems to ensure product excellence.

    + Lead, mentor, and develop the quality team to achieve organizational goals.

    Essential Skills

    + Minimum of 5 years managing direct reports.

    + Strong knowledge in ISO:2016 and FDA regulations for Class III medical devices.

    + Proven experience in Quality Management roles during FDA inspections or audits.

    Additional Skills & Qualifications

    + Minimum 2 years in quality management or leading a team within the medical device industry.

    + Strong understanding of manufacturing quality and quality control.

    + Experience with FDA QSR and ISO:2026.

    + Familiarity with Class II or III medical devices.

    Work Environment

    The work environment is a medical device manufacturing setting located in Longmont, CO. It features various clean room setups across multiple buildings within the business park. The company is experiencing rapid growth and offers development opportunities, with a best-in-class engineering team onsite

    Pay and Benefits

    The pay range for this position is $52.40 - $72.11/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 Longmont,CO.

     

    Application Deadline

     

    This position is anticipated to close on May 5, 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.