• Quality Engineer

    Actalent (Fort Wayne, IN)


    Job Title: Quality Engineer

    Job Description

    The Quality Engineer is tasked with supporting the mission of delivering high-performance medical wire and components. This role emphasizes driving quality excellence across CAPA processes, GD&T inspection, and vendor product quality assurance. The ideal candidate will work collaboratively across functions to ensure compliance with regulatory standards and meet customer expectations.

    Responsibilities

    + Lead and support investigations for non-conformances and conduct root cause analysis using tools such as 5 Whys and FMEA.

    + Develop and implement effective Corrective and Preventive Action (CAPA) plans.

    + Monitor the effectiveness of CAPA and ensure timely closure of actions.

    + Maintain CAPA documentation in line with ISO, FDA QSR, and internal quality system requirements.

    + Interpret engineering drawings and specifications with Geometric Dimensioning and Tolerancing (GD&T) annotations.

    + Perform dimensional inspections using precision metrology tools such as CMM, calipers, and micrometers.

    + Document inspection results and ensure measurement traceability.

    + Collaborate with design and manufacturing teams to resolve GD&T-related issues.

    + Support validation and verification activities for new and modified products.

    + Conduct incoming inspections and quality audits of vendor-supplied products.

    + Review and approve supplier quality documentation, including PPAP, FAI, and Certificates of Analysis (COA).

    + Communicate quality issues to vendors and support resolution efforts.

    + Monitor supplier performance metrics and initiate improvement plans as needed.

    + Ensure compliance with regulatory, customer, and company-specific quality standards.

    Essential Skills

    + 2+ years of Quality Engineering experience with a STEM degree or 4+ years of experience without a degree (degree is preferred).

    + Experience with quality documentation and CAPA support including root cause analysis and corrective action plans.

    + Familiarity with quality system compliance.

    + Experience with GD&T testing documentation and collaboration with design and manufacturing teams.

    + Experience in PPAP review and audits, root cause analysis, supplier quality, quality inspection, fishbone diagrams, and FMEA.

     

    Additional Skills & Qualifications

     

    + Experience with the Medical Device industry.

    + ASQ Certification.

    Work Environment

    The work environment involves collaborating with cross-functional teams and using advanced precision metrology tools. The role requires adherence to regulatory standards and emphasizes quality assurance in a dynamic and innovative setting.

     

    Job Type & Location

     

    This is a Contract position based out of Fort Wayne, Indiana.

    Pay and Benefits

    The pay range for this position is $35.00 - $45.00/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 Fort Wayne,IN.

     

    Application Deadline

     

    This position is anticipated to close on Nov 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.