Design Quality Engineer (Consultant) - Medical Device

Design Quality Assurance Engineer (Consultant) – Medical Device Location: North Carolina – Onsite Preferred Duration: 12-Month Contract (Full-Time, 40 hrs/week) About the Opportunity Peritia 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 Matters The 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 Responsibilities Serve as the Design Quality representative on cross-functional NPD/NPI core teams Lead design control activities including design planning, inputs/outputs, reviews, and DHF documentation Drive 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 manufacturing Partner with supply chain on supplier qualification, audits, and NPI readiness Ensure compliance with FDA, ISO 13485, and global regulatory requirements Identify gaps in testing, documentation, and risk justification; recommend corrective actions Provide risk-based decision-making support and uphold quality standards under timeline pressure Collaborate with global teams across U.S. and UK sites to ensure consistency in execution Required Qualifications Bachelor’s degree in Engineering or related technical field 5–7 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 programs Strong knowledge of design controls, verification & validation, and risk management Experience working in regulated environments (FDA, ISO 13485) Ability to work independently and influence cross-functional teams Preferred Experience Combination product or drug-device experience Prototyping, pilot builds, and early production support Supplier quality and audit experience during NPI Statistical analysis and tools such as Minitab Experience in small to mid-sized or fast-paced organizations Strong communication skills with the ability to challenge decisions constructively What Success Looks Like Acting as an independent quality leader who can “hold the line” when needed Supporting risk-based decisions that prevent audit findings and downstream issues Driving structure and rigor in a fast-growing, globally distributed environment Location: Greater Charlotte, NC area – Onsite preferred #J-18808-Ljbffr Peritia