Gandiv Insights LLC · 15 hours ago
Design Quality Engineer
Minneapolis, MN
Contract
Onsite
Senior Level
5+ years expGandiv Insights LLC is seeking a Design Quality Engineer to support medical device development by leading design control activities and ensuring compliance with FDA and ISO requirements. The role involves overseeing verification, validation, and process validation activities to ensure product quality throughout the lifecycle.
Information Technology & Services
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
Qualification
Required
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
Preferred
CMO or catheter device experience is a plus
Company
Gandiv Insights LLC
Gandiv Insights is a leading professional services and staffing firm specializing in top-tier personnel and technical solutions across engineering, IT, non-IT, and healthcare sectors.
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase