Save Job Back to Search Job Description Summary Similar JobsLead quality initiatives for cutting-edge medical manufacturing programsOwn high-impact projects with visibility across engineering and leadershipAbout Our ClientOur client is a growing advanced manufacturing organization known for delivering highly engineered products used in demanding and regulated industries. The company offers a collaborative environment where quality and innovation are central to business success, creating strong opportunities for professional growth and impact.Job DescriptionSupport and enhance the Quality Management System (QMS) to ensure ongoing compliance and effectivenessPartner with leadership and cross-functional teams to maintain ISO 13485 compliance standardsMentor and train Quality Engineers while supporting onboarding and professional developmentLead root cause investigations and provide hands-on manufacturing support to improve production performanceOwn FMEA activities and risk management processes across products and manufacturing operationsManage customer complaints, RMAs, and customer-facing quality issuesSupport equipment qualification and validation efforts including IQ, OQ, and PQ protocolsConduct Measurement System Analysis (MSA) and Gage R&R studiesImplement new inspection technologies and quality control methodologiesLead continuous improvement projects through statistical analysis and data-driven decision makingManage change control processes and associated risk assessmentsSupport supplier quality programs, evaluations, and approved supplier managementDevelop and revise SOPs, work instructions, and quality documentationPerform product inspections and quality reviews as neededMPI 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, Quality, Manufacturing, or a related technical field5-10 years of quality engineering experience within medical device or medical component manufacturingStrong understanding of Quality Management Systems and ISO 13485 requirementsExperience with CAPA, nonconformance management, calibration, and root cause analysisHands-on knowledge of FMEA and risk management methodologiesExperience with validation protocols including IQ, OQ, and PQProficiency with metrology equipment including vision systems, microscopes, profilometers, and precision measurement toolsAbility to interpret technical drawings, blueprints, and GD&TStrong statistical analysis skills with experience using Minitab or similar softwareExperience supporting FDA, customer, or registrar audits is highly desirableAdvanced Microsoft Office skills, including Excel and data analysis capabilitiesPortuguese language skills are a plusWhat's on OfferSalary of $110,000 to $130,000.Join a stable and growing organization serving regulated, high-tech industriesMake a direct impact on product quality, compliance, and operational excellenceGain exposure to advanced manufacturing technologies and processesWork closely with executive leadership and cross-functional engineering teamsEnjoy a role with significant ownership, autonomy, and career advancement potentialContactKyle PerryQuote job refJN-102026-7131189Job summarySectorEngineering & ManufacturingSub SectorQuality, TechnicalIndustryIndustrial / ManufacturingWhereNorwoodContract TypePermanentConsultant nameKyle PerryJob ReferenceJN-102026-7131189
