Quality Engineer

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

Additional Skills & Qualifications

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 :

Workplace Type

This is a fully onsite position in Fort Wayne,IN.

Application Deadline

This position is anticipated to close on Nov 5, 2025.