Quality & Design Engineer

Quality & Design Engineer

Join to apply for the Quality & Design Engineer role at Katalyst CRO
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• 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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