Medical Device Supplier Quality Engineer - MDQE#001 at NavitsPartners Madison, WI

Comunidade Metodista; Madison (WI); Sur place; USD 47 000 - 63 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

QMS knowledge

Design change management

Reading drawings

BOM interpretation

Cross-functional collaboration

Formation

Bachelor's in Electrical or Mechanical Engineering

Description du poste

Job Title: Medical Device Supplier Quality Engineer

Location: Waukesha, WI

Type: Contract (11 Months)

Rate: $40/hour

Position Overview

We are seeking a skilled Supplier Quality Engineer with a strong background in medical devices to support supplier transfer projects and ensure compliance with regulatory standards. The role requires hands-on experience in design change management, supplier collaboration, and quality verification processes.

Key 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 Bill of Materials (BOM).

• 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.

Required Skills & Qualifications

• Degree in Electrical or Mechanical Engineering (a mix of both disciplines preferred).

• Strong understanding of Medical Device Quality Management Systems (QMS) and related processes.

• Proven experience managing end-to-end design change projects.

• Electrical engineering background with knowledge of medical device standards (preferred).

• Experience with design change activities: inputs, requirements, verification, and transfer.

• Ability to read and interpret engineering specifications, technical drawings, and BOMs.