Gandiv Insights LLC ยท 16 hours ago
Design Quality Engineer
Princeton, NJ
Contract
Hybrid
Mid LevelGandiv Insights LLC is seeking a Design Quality Engineer to support Design Control and Quality activities throughout the product development lifecycle. The role involves ensuring compliance with FDA, ISO, and GMP requirements while collaborating with various teams to drive compliant product design from concept through commercialization.
Information Technology & Services
Responsibilities
Support Design Controls (URS, DHF, DMR, DVP&R)
Participate in risk management activities (FMEA, hazard analysis, ISO 14971)
Support design verification and validation (DV/V) activities
Review and approve design and technical documentation
Support change control, deviations, and CAPA related to design changes
Ensure compliance with FDA 21 CFR 820, ISO 13485, and GMP requirements
Support audits and regulatory inspections
Qualification
Required
Experience in pharma or medical device Design Quality
Strong knowledge of Design Controls and Quality Systems
Hands-on experience with risk management and DV/V
Familiarity with FDA, ISO, and GxP regulations
Strong documentation, communication, and cross-functional skills
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