• Quality Engineering Lead - EU MDR Remediation

    Actalent (Centennial, CO)


    Job Title: Quality Engineering Lead - EU MDR Remediation Job Description

     

    We are seeking an experienced Quality Lead to support a high-impact EU MDR remediation project for a leading medical device company. This remote consulting role will be responsible for driving the quality workstream across two critical phases of the project: Gap Assessment and Technical File Remediation. The ideal candidate will bring deep expertise in medical device quality systems, EU MDR requirements, and technical documentation. This role requires strong leadership and collaboration skills, as the Quality Lead will oversee an offshore quality resource in Phase 1 and manage a larger team during Phase 2.

    Responsibilities

    + Lead the execution of the quality portion of the EU MDR gap assessment.

    + Review existing technical documentation and identify compliance gaps.

    + Collaborate with cross-functional teams to gather necessary inputs.

    + Oversee and guide an offshore Quality Lead to ensure alignment and consistency.

    + Drive the remediation of technical files to meet EU MDR requirements.

    + Develop and implement quality strategies and documentation updates.

    + Manage a larger team of quality professionals, ensuring timely and compliant deliverables.

    + Provide quality oversight and ensure adherence to regulatory standards and internal procedures.

    Essential Skills

    + Quality engineering

    + Remediation

    + EU MDR

    + DHF

    + Risk Management

    + Gap Assessment

    + Technical File Remediation

    + Quality Assurance

    Additional Skills & Qualifications

    + Bachelor’s degree in Engineering, Life Sciences, or related field (Master’s preferred).

    + Minimum 7 years of experience in medical device quality assurance.

    + Proven experience with EU MDR compliance and technical documentation.

    + Strong understanding of ISO, 21 CFR Part 820, and global regulatory requirements.

    + Excellent communication, leadership, and project management skills.

    + Prior consulting experience in medical device regulatory projects.

    + Ability to work independently and manage multiple priorities in a fast-paced environment.

    + Experience managing remote and offshore teams.

    Work Environment

    This is a remote consulting role offering 2 weeks of PTO and 6 paid holidays. The role involves managing both onshore and offshore teams, requiring flexibility and excellent communication skills to ensure effective collaboration across different time zones.

     

    Job Type & Location

     

    This is a Contract position based out of Centennial, Colorado.

    Pay and Benefits

    The pay range for this position is $50.00 - $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 remote position.

     

    Application Deadline

     

    This position is anticipated to close on Oct 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.