Quality Engineer, Development (New Product Introduction)

Quality Engineer, Development (New Product Introduction)Location: Onsite / Hybrid (as applicable)Employment Type: Contract to HirePosition SummaryWe are seeking a Quality Engineer, Development to support New Product Introduction (NPI) activities within a regulated medical device manufacturing environment. This role provides quality engineering support throughout the development lifecycle, including validation documentation, measurement method qualification, and process readiness as new products transition into production. The ideal candidate is detail‑oriented, collaborative, and comfortable managing multiple development projects simultaneously.Key ResponsibilitiesProvide quality engineering support to development and NPI programsLead root cause analysis of manufacturing and process issues identified during the development cycleFacilitate and author Process Failure Mode and Effects Analyses (PFMEAs)Author and maintain development‑stage quality documentation, including:Process flow diagramsMaster Validation PlansProcess Qualification protocols and reportsTest plans and sampling strategiesTest Method Validation protocols and reportsWork instructions and control plansSupport development of inspection and measurement methods, including receiving inspection instructionsPerform capability analysis of process, test, and qualification data using statistical toolsRepresent the Quality function in cross‑functional project meetings and ensure timely completion of assigned deliverablesApply Lean and Six Sigma (DMAIC) principles to support continuous improvement effortsQualificationsBachelor of Science in Engineering or a related technical disciplineEquivalent combinations of education and experience may be considered2+ years of experience in medical device manufacturing or development (internship experience acceptable)Experience supporting development‑stage or NPI quality engineeringWorking knowledge of ISO 13485 and GMP requirementsExperience with validation, PFMEAs, control plans, and test method developmentAbility to read and interpret engineering drawings, specifications, and GD&TProficiency with Minitab and Microsoft OfficeCAD modeling experience preferredStrong written and verbal communication skills with the ability to present information at multiple organizational levelsWork EnvironmentMedical device manufacturing and development settingProject‑driven, collaborative environment supporting new product launches