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Design Quality Engineer
Gandiv Insights LLC
- Minneapolis, Minnesota, United States
- Minneapolis, Minnesota, United States
About
Design Quality Engineer
Location: Minneapolis, MN
Contract(W2 only)
Role Overview
We are seeking a Design Quality Engineer to support medical device development by leading design control activities and ensuring successful execution of verification, validation, and process validation activities in compliance with FDA and ISO requirements.
Key Responsibilities
- Lead design control deliverables and maintain the Design History File (DHF)
- Plan and execute design verification, validation, and process validation (IQ/OQ/PQ/PPQ)
- Translate user needs into measurable, traceable product requirements
- Perform and maintain risk management activities across the product lifecycle
- Develop test methods, inspection plans, and sampling strategies
- Support supplier quality, FAI, audits, and external manufacturing partners
- Lead root cause analysis, CAPA, and manufacturing issue resolution
- Review and approve change controls, deviations, and nonconformances
- Support biocompatibility, sterilization, and equipment qualification
Requirements
- 5+ years of medical device quality/design quality experience
- Strong knowledge of design controls, validation, and ISO 13485
- Experience with supplier quality, FAI, and audits
- Experience working in cross-functional development teams
- CMO or catheter device experience is a plus
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Languages
- English
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