Medical Device Supplier Quality Engineer: Transfers

Comunidade Metodista; Madison (WI); On-site; USD 47,000 - 63,000; Full time

Job summary

Comunidade Metodista in Wisconsin is seeking a Medical Device Supplier Quality Engineer for an 11-month contract to drive supplier transfer projects and ensure compliance with medical device QMS standards.

You will manage ECRs/ECOs, develop qualification plans, verify transferred items through FAIRs, and collaborate with engineering and suppliers to implement design changes and maintain robust quality processes across all transfers.

Qualifications

• Degree in Electrical or Mechanical Engineering (or both disciplines) required.
• Strong understanding of Medical Device Quality Management Systems (QMS) and related processes.
• Proven experience managing end-to-end design change projects.
• Ability to read and interpret engineering drawings and BOMs.

Responsibilities

• Develop qualification plans for supplier transfer projects and perform associated verification testing.
• Manage and execute Engineering Change Requests (ECRs) and Engineering Change Orders (ECOs).
• Collaborate with engineering and cross-functional teams to ensure seamless project execution.
• Compile design packages including drawings, specifications, and BOMs.
• Work directly with suppliers to clarify requirements and address technical inquiries.
• Drive design changes to add or update approved suppliers.
• Conduct verification of transferred items and manage First Article Inspections (FAIRs).
• Partner with modality engineers to assess scope and impact of supplier transfers.

Skills

QMS knowledge

Design change management

Reading drawings

BOM interpretation

Cross-functional collaboration

Education

Bachelor's in Electrical or Mechanical Engineering

Job description

Comunidade Metodista in Wisconsin is seeking a Medical Device Supplier Quality Engineer for an 11-month contract to drive supplier transfer projects and ensure compliance with medical device QMS standards.

You will manage ECRs/ECOs, develop qualification plans, verify transferred items through FAIRs, and collaborate with engineering and suppliers to implement design changes and maintain robust quality processes across all transfers.