Senior Quality Engineer

Senior Quality EngineerLocation: OnsiteEmployment Type: Full-TimeAbout UsWe are an innovative medical device company focused on developing and manufacturing technologies that improve patient outcomes and advance healthcare. Our team operates in a fast-paced, collaborative environment where quality, compliance, and continuous improvement are core to everything we do.We are seeking a highly motivated Senior Quality Engineer to support manufacturing operations, product quality, and quality system compliance for Class II and/or Class III medical devices.Position SummaryThe Senior Quality Engineer will play a key role in supporting product realization, manufacturing quality, process validation, supplier quality, and post-market quality activities. This individual will work cross-functionally with Manufacturing, R&D, Regulatory Affairs, Operations, and Supply Chain teams to ensure products meet customer expectations and regulatory requirements.The ideal candidate has strong experience within regulated medical device environments and thrives in a dynamic setting requiring both strategic thinking and hands-on execution.Key ResponsibilitiesLead and support quality engineering activities for manufacturing operations and product development programs.Drive investigations related to nonconformances, complaints, CAPAs, deviations, and returned product analysis.Perform root cause analysis using structured problem-solving methodologies and implement effective corrective/preventive actions.Develop, review, and approve quality documentation including protocols, reports, procedures, specifications, and validation documents.Support process validation activities including IQ/OQ/PQ and equipment qualification efforts.Partner with suppliers to ensure component and material quality requirements are met.Support risk management activities including FMEAs, hazard analyses, and risk assessments in accordance with ISO 14971.Collaborate with cross-functional teams to drive continuous improvement initiatives and manufacturing process optimization.Analyze quality data, trends, and metrics to identify areas for improvement and support management reviews.Participate in internal and external audits and support regulatory inspections.Ensure compliance with FDA QSR, ISO 13485, and other applicable global regulatory requirements.Support design transfer and commercialization activities for new product introductions.Mentor junior engineers and provide technical guidance as needed.QualificationsRequired QualificationsBachelor’s degree in Engineering, Life Sciences, or related technical discipline.5+ years of Quality Engineering experience within the medical device industry.Working knowledge of:FDA 21 CFR Part 820ISO 13485CAPA systemsRisk managementRoot cause analysis methodologiesExperience supporting manufacturing quality and/or supplier quality activities.Strong technical writing, analytical, and problem-solving skills.Experience with statistical analysis and quality tools.Ability to work effectively in cross-functional and fast-paced environments.Preferred QualificationsExperience with Class III medical devices.ASQ Certified Quality Engineer (CQE) certification.Experience with design controls and verification/validation activities.Familiarity with Lean Manufacturing and Six Sigma methodologies.Experience supporting audits and regulatory inspections.Knowledge of EU MDR and international regulatory standards.What We OfferCompetitive salary and bonus opportunitiesComprehensive medical, dental, and vision coverage401(k) with company matchPaid time off and company holidaysCareer growth and professional development opportunitiesCollaborative and mission-driven cultureEqual Opportunity EmployerWe are an Equal Opportunity Employer and value diversity at all levels of the organization. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic