Senior Design Quality Engineer
Intellectt INC
Hiring: Senior Design Quality Engineer Design Assurance
Location: Arden Hills, MN
We're hiring a Senior Design Quality Engineer in Arden Lakes, MN. Looking for candidates with a Bachelor's degree, Medical Device Design Quality, Design Controls, CAPA, Risk Management, and DHF experience.
Key Responsibilities:
Support Design Quality activities for medical device products
Work with R&D, Engineering, Manufacturing, and Quality teams
Review design documents, drawings, specifications, and test plans
Support design changes, material changes, and product improvements
Support CAPA, root cause analysis, and corrective actions
Review Design History Files (DHF) and design control documents
Support design verification, validation, and test method development
Perform risk assessments and support risk management activities
Ensure design activities meet quality and regulatory requirements
Analyse quality and engineering data and provide recommendations
Support continuous improvement and product quality initiatives
Requirements:
Bachelor's degree in Engineering or a related technical field
Experience in Medical Devices, Design Quality, Quality Engineering, or R&D
Experience with medical device design controls and one-time-use devices
Knowledge of DHF, CAPA, Risk Management, Design Verification, and Traceability
Experience reviewing engineering drawings and technical documents
Experience with test methods, verification, and validation
Strong documentation and report-writing skills
Ability to work independently and solve technical problems
Good communication and teamwork skills
Vacancy posted 1 day ago
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