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Job Title: Quality EngineerJob Description

The Quality Engineer is responsible for supporting the mission of delivering high-performance medical wire and components. This role focuses on driving quality excellence across CAPA processes, GD&T inspection, and vendor product quality assurance. The ideal candidate will collaborate cross-functionally to ensure compliance with regulatory standards and 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 CAPA effectiveness and ensure timely closure.

+ Maintain CAPA documentation in accordance 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 CMM, calipers, micrometers, and other precision metrology tools.

+ Document inspection results and ensure traceability of measurements.

+ 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 as a Quality Engineer without a degree (degree is preferred).

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

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

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

Additional Skills & Qualifications

+ Experience in the Medical Device industry.

+ ASQ Certification.

Work Environment

The work environment includes the use of precision metrology tools such as CMM, calipers, and micrometers. The role requires collaboration with cross-functional teams, including design and manufacturing, to ensure quality standards are met. The position may involve working with regulatory and customer-specific quality standards.

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 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.