• Quality Assurance Engineer

    Actalent (Louisville, CO)


    Job Title: Quality Assurance Engineer

    Job Description

    We are seeking a dedicated Quality Assurance Engineer to lead and execute an ISO risk management remediation initiative. This role involves updating risk procedures, remediating risk files, and ensuring alignment with design controls and post-market processes. The position requires a blend of project management skills and hands-on remediation work, with a strong emphasis on collaboration with internal teams.

    Responsibilities

    + Lead ISO risk management remediation initiatives.

    + Update risk procedures to comply with international standards.

    + Remediate risk files to ensure they meet regulatory requirements.

    + Align risk management activities with the product development lifecycle.

    + Incorporate real-world data into risk assessments and updates.

    + Develop strategies and timelines for project management and coordinate remediation activities.

    Essential Skills

    + Experience with ISO risk management in a regulated environment, preferably in medical devices.

    + Strong knowledge of design controls and post-market processes.

    + Proven project management skills.

    + Excellent communication and organizational abilities.

    + 5-6+ years of relevant experience.

     

    Additional Skills & Qualifications

     

    + Familiarity with FDA and EU MDR regulations.

    + Prior experience in risk file remediation projects.

    + Ability to work independently and collaboratively across functions.

    Work Environment

    This position is based on-site in Louisville, CO, with potential for hybrid flexibility. The environment is fast-paced and compliance-driven, fostering collaboration among cross-functional teams.

     

    Job Type & Location

     

    This is a Contract position based out of Louisville, CO.

    Pay and Benefits

    The pay range for this position is $53.00 - $70.00/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 Louisville,CO.

     

    Application Deadline

     

    This position is anticipated to close on Dec 10, 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.