Supplier Quality Engineer

Supplier Quality Engineer

Duration: 9 mo with extensions

Location:

Warsaw IN/ MN

Start: ASAP

Position Summary:
We are seeking a Supplier Quality Engineer with strong experience in the medical device industry to support supplier selection, qualification, and ongoing quality performance. This role will play a key part in ensuring suppliers meet regulatory and quality standards for both capital equipment and single-use sterile devices, with a strong emphasis on PCB components and testing.

Key Responsibilities:

• Lead supplier selection, evaluation, and qualification activities
• Manage component qualification processes, including PPAP submissions
• Partner closely with suppliers to define and review PCB testing methods, inspection criteria, and acceptance standards
• Oversee and validate how PCB components are tested, including functional testing, electrical testing, and verification activities
• Ensure proper verification and validation of PCB components to meet design and regulatory requirements
• Conduct supplier audits (onsite and remote) and drive corrective actions
• Support development and validation of test methods, including those specific to PCB assemblies
• Collaborate with cross‑functional teams on design transfer, verification, and manufacturing readiness
• Perform and support DFMEA activities to identify and mitigate risk
• Drive continuous improvement initiatives with suppliers

Preferred Qualifications:

• Experience with single‑use sterile medical devices
• Strong PCB experience
• Working knowledge of FDA and ISO 13485 requirements