Design Quality Assurance Engineer (Consultant) – Medical DeviceLocation: North Carolina – Onsite PreferredDuration: 12-Month Contract (Full-Time, 40 hrs/week)About the OpportunityPeritia is partnering with a global medical device and combination product organization to engage a Design Quality Assurance Engineer to support critical new product development (NPD) and new product introduction (NPI) initiatives.This role sits within a growing Global Quality organization and will play a key role in advancing a high-priority FY2027 product pipeline across U.S. and UK operations.Why This Role MattersThe organization currently lacks a dedicated quality lead for NPD/NPI programs. As a result, this position is highly visible and impactful—responsible for ensuring design control rigor, audit readiness, and regulatory compliance while enabling efficient product commercialization.You will be the quality voice at the table, partnering directly with engineering, program management, and supply chain teams to ensure the right balance between speed and compliance.Key ResponsibilitiesServe as the Design Quality representative on cross-functional NPD/NPI core teamsLead design control activities including design planning, inputs/outputs, reviews, and DHF documentationDrive risk management activities in accordance with ISO 14971 (hazard analysis, risk assessments, mitigation strategies)Review and support verification and validation activities (including IQ/OQ/PQ where applicable)Provide quality oversight during prototyping, pilot builds, and early manufacturingPartner with supply chain on supplier qualification, audits, and NPI readinessEnsure compliance with FDA, ISO 13485, and global regulatory requirementsIdentify gaps in testing, documentation, and risk justification; recommend corrective actionsProvide risk-based decision-making support and uphold quality standards under timeline pressureCollaborate with global teams across U.S. and UK sites to ensure consistency in executionRequired QualificationsBachelor's degree in Engineering or related technical field5–7 years of experience in medical device, pharmaceutical, or combination product environments (strong candidates with 2–3 years considered)Hands-on experience in Design Quality / Design Assurance supporting NPD or NPI programsStrong knowledge of design controls, verification & validation, and risk managementExperience working in regulated environments (FDA, ISO 13485)Ability to work independently and influence cross-functional teamsPreferred ExperienceCombination product or drug-device experiencePrototyping, pilot builds, and early production supportSupplier quality and audit experience during NPIStatistical analysis and tools such as MinitabExperience in small to mid-sized or fast-paced organizationsStrong communication skills with the ability to challenge decisions constructivelyWhat Success Looks LikeActing as an independent quality leader who can “hold the line” when neededSupporting risk-based decisions that prevent audit findings and downstream issuesDriving structure and rigor in a fast-growing, globally distributed environmentLocation: Greater Charlotte, NC area – Onsite preferred#J-18808-Ljbffr