Save Job Back to Search Job Description Summary Similar JobsLead design quality and risk activities across product development.Ensure compliant, high-quality product delivery across teams.About Our ClientOur client is a medical device organization focused on developing and commercializing innovative technologies within a highly regulated environment. Operating under stringent global quality and regulatory standards, including ISO 13485 and FDA requirements, they emphasize strong collaboration between product development and quality teams to ensure safe, effective, and compliant products. Their culture promotes technical rigor, accountability, and continuous improvement across the product lifecycle.Job DescriptionServe as the Design Controls Subject Matter Expert, ensuring proper execution of all design control phasesAct as the quality lead on product development teams, ensuring compliance with internal procedures and global regulatory requirementsOwn and maintain Design History Files (DHF), ensuring completeness and accuracy throughout development phasesLead risk management activities, including authoring plans and reports and facilitating cross-functional risk assessmentsEnsure all applicable technical standards and design requirements are incorporated into new and modified productsReview and approve Engineering Change Orders (ECOs) from external manufacturers and assess associated risk documentationSupport development, review, and maintenance of quality procedures, documentation, and technical data formsEnsure adherence to Quality Management System (QMS) processes and documentation requirementsReview validation protocols and reports to ensure GMP and regulatory complianceLead investigations into non-conformances, customer complaints, and CAPAs, ensuring timely resolutionSupport internal audit activities and ongoing QMS maintenance and improvement effortsProvide training and guidance on quality systems, design controls, and engineering best practicesMaintain knowledge of global standards and regulations, including ISO 13485, FDA 21 CFR Part 820/812, MDR, and MDSAPCollaborate cross-functionally with engineering, manufacturing, regulatory, and external partnersMPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.The Successful ApplicantBachelor's degree in Engineering (Electrical Engineering preferred)5-10 years of experience in the medical device industry or regulated environmentStrong experience in design controls, risk management, and quality or product development engineeringDeep knowledge of global quality and regulatory standards (ISO 13485, FDA 21 CFR Part 820, MDSAP, MDR)Experience with medical instrumentation or complex technical productsStrong technical writing and documentation skillsProven ability to work independently with minimal supervisionExcellent analytical, problem-solving, and root cause investigation capabilitiesStrong communication and organizational skills with ability to influence cross-functional teamsProficiency with MS Office tools (Word, Excel) and quality documentation systemsExperience in regulated industries such as medical devices, defense, or related highly controlled environments preferredWhat's on OfferCompetitive salary with strong growth potential in a high-impact individual contributor roleComprehensive benefits package (medical, dental, vision, etc.)Opportunity to play a key role in product development and regulatory compliance for innovative medical technologiesExposure to cross-functional leadership and global regulatory environmentsAbility to drive quality excellence across engineering and product development teamsContactAlexander TveterQuote job refJN-062026-7037174Job summarySectorEngineering & ManufacturingSub SectorQuality, TechnicalIndustryIndustrial / ManufacturingLocationPhiladelphiaContract TypePermanentConsultant nameAlexander TveterJob ReferenceJN-062026-7037174
