• Principal Specialist, Quality Management Systems…

    Actalent (Cary, IL)


    Job Title: Principal Specialist, Quality Management Systems - Specialized Individual ContributorJob Description

     

    This position involves working within the Quality Management Systems (QMS) to conduct GAP assessments for quality systems, specifically for 510Ks in the US and EUMDR. The role focuses on gastrointestinal-type devices and requires close collaboration with Regulatory Affairs (RA).

    Responsibilities

    + Conduct GAP assessments in the quality system for 510Ks and EUMDR.

    + Collaborate closely with Regulatory Affairs on gastrointestinal-type devices.

    + Ensure compliance with US and International Medical Device Regulations, including MDSAP.

    + Apply strong knowledge of Quality Systems, including Measurement, Analysis, and Improvement; Adverse Event and Advisory Reporting; Purchasing; Design and Development; Production and Service Controls.

    + Maintain expert working knowledge of regulatory requirements, standards, and regulations.

    + Conduct audits and ensure quality compliance.

    + Communicate effectively across different levels of the organization.

    + Plan, organize, and implement multiple concurrent tasks.

    + Provide analytical and problem-solving expertise to draw insights from data and define executable actions.

    + Work in cross-functional team environments to achieve desired outcomes.

    + Develop technical writing and procedures.

    + Handle compliance risk situations and provide solutions.

    + Travel as required to fulfill job responsibilities.

    Essential Skills

    + 9+ years of experience in the medical device industry and working with regulatory agencies.

    + In-depth knowledge and experience with US 510(k) and EU Class II devices.

    + Strong understanding of US and International Medical Device Regulations, including MDSAP.

    + Expertise in Quality Systems and regulatory requirements.

    + Significant audit experience.

    + Excellent communication, project management, and influencing skills.

    + Strong interpersonal skills and negotiation capabilities.

    + Proficiency in technical writing and computer literacy.

    Additional Skills & Qualifications

    + Experience in compliance risk situations.

    + Ability to make sound decisions and develop appropriate solutions.

    + Customer service/stakeholder-focused approach.

    + Experience in data review and analysis.

    Work Environment

    The position is based in an office environment with a flexible work arrangement, requiring attendance in the office from Monday to Friday, and remote work from Tuesday to Friday. Candidates must be local to Illinois.

     

    Job Type & Location

     

    This is a Contract position based out of Cary, Illinois.

    Pay and Benefits

    The pay range for this position is $57.00 - $87.00/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 Cary,IL.

     

    Application Deadline

     

    This position is anticipated to close on Oct 24, 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.