Save Job Back to Search Job Description Summary Similar JobsFDA-approved products driving rapid growthApply today to be considered within 24 hours!About Our ClientOur client is a medical device innovator develops precision-engineered technologies that improve patient and caregiver experiences in vascular access procedures. With multiple recent regulatory approvals and an expanding product pipeline, the organization is building momentum while maintaining the agility and visibility of a startup environment.Job DescriptionThis Senior Quality Engineer will be responsible for:Supporting and improving the Quality Management System (QMS)Partnering with R&D on design controls and product development activitiesLeading risk management activities in compliance with ISO 14971Investigating nonconformances, complaints, and CAPAsManaging supplier qualification, monitoring, and quality performanceConducting root cause investigations and product failure analysisSupporting process validation and manufacturing transfer activitiesReviewing engineering changes for quality and regulatory impactMonitoring quality metrics and driving continuous improvement initiativesSupporting contract manufacturing operations and supplier relationshipsAssisting with internal audits, supplier audits, and inspection readinessServing as a key quality resource for engineering and manufacturing teamsMPI 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 ApplicantA Successful Senior Quality Engineer will have:7+ years of medical device industry experience.5+ years in Quality Engineering or Quality Assurance roles.Strong knowledge of ISO 13485, ISO 14971, FDA/QSR requirements, and medical device regulations.Experience with supplier qualification, supplier audits, and supplier quality management.Experience supporting CAPA, complaint handling, risk management, and nonconformance investigations.Hands-on validation experience including IQ/OQ/PQ and process validation.Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.Experience in Class II medical devices; startup experience is highly desirable.What's on OfferBonus opportunity based on level.Potential equity participationDirect exposure to executive leadership and company growth.15 days PTO plus 7 paid holidays.Medical, dental, and vision coverage.401(k) plan with future company match under consideration.Apply today to be considered within 24 hours!ContactAshley SantosQuote job refJN-082026-7089391Job summarySectorEngineering & ManufacturingSub SectorProduction, ManufacturingIndustryIndustrial / ManufacturingWhereInternationalContract TypePermanentConsultant nameAshley SantosJob ReferenceJN-082026-7089391
