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Quality & Design Engineer
Job in
Waukesha, Waukesha County, Wisconsin, 53188, USA
Listed on 2026-01-12
Listing for:
Katalyst CRO
Full Time
position Listed on 2026-01-12
Job specializations:
-
Engineering
Quality Engineering
Job Description & How to Apply Below
Quality & Design Engineer
Join to apply for the Quality & Design Engineer role at Katalyst CRO
.
- Develop qualification plans for supplier transfer projects and complete associated verification testing.
- Manage and execute Engineering Change Requests (ECRs) and Engineering Change Orders (ECOs).
- Collaborate effectively within engineering and cross‑functional teams.
- Pull together design packages including drawings, specifications, and Bill of Material (BOM).
- Work with suppliers to understand requirements and answer technical questions.
- Drive design changes (ECOs) to add alternate supplier or change the approved supplier.
- Drive verification of transferred items and First Article Inspections (FAIRs).
- Partner with Modality engineers to understand scope and impact of the transfer.
- Background in Electrical or Mechanical Engineering (mix of Mechanical & Electrical Engineers ideal).
- Solid understanding of Medical Device Quality Management System (QMS) processes, with hands‑on experience.
- Proven experience managing end‑to‑end design change projects.
- Electrical Engineering background, preferably with medical device knowledge.
- Design Change experience (Inputs, Requirements, Verification, Transfer).
- Ability to read and interpret engineering specifications, drawings, and BOMs.
- Entry level
- Contract
- Quality Assurance
- Pharmaceutical Manufacturing
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