Quality Engineer

Quality Engineer Position Summary The Quality Engineer is responsible for ensuring product quality, regulatory compliance, and continuous improvement within a fast-paced medical device manufacturing environment. This role partners with Engineering, Manufacturing, Operations, and Regulatory Affairs to maintain compliance with FDA and ISO requirements while supporting product development, process improvements, risk management, and quality system effectiveness throughout the product lifecycle. This position provides an opportunity to make a direct impact on patient safety, product quality, and operational excellence. Work Location & Employment RequirementsThis is a fully onsite position and requires regular attendance at our manufacturing facility.Relocation assistance is not available for this position.Visa sponsorship is not available now or in the future.Candidates must be legally authorized to work in the United States without current or future sponsorship requirements.What You'll Be Doing:Maintain and improve the Quality Management System (QMS) in compliance with FDA 21 CFR Part 820, ISO 13485, and other applicable regulationsLead CAPA, NCR, root cause investigations, and corrective action activitiesSupport validation activities, including IQ/OQ/PQ, test method validation, and software validation as applicableDevelop and execute Gage R&R studies and inspection methodologiesPerform risk management activities, including FMEA and hazard analysesSupport internal, customer, supplier, and regulatory auditsCollaborate with Engineering, Manufacturing, and Regulatory Affairs to ensure quality requirements are met throughout the product lifecycleMonitor quality metrics and drive continuous improvement initiatives using Lean Manufacturing and Six Sigma methodologiesSupport supplier quality activities, including supplier audits, evaluations, and incoming inspection processesParticipate in design reviews and support design controls, DHR, DMR, and DHF documentationSupport implementation and maintenance of electronic Quality Management Systems (eQMS)Contribute to regulatory submissions, complaint investigations, and post-market quality activitiesDevelop and deliver quality-related training as neededRequired QualificationsBachelor's degree in Engineering, Life Sciences, or a related technical disciplineMinimum of 3-5 years of Quality Engineering experience in a regulated manufacturing environmentWorking knowledge of FDA 21 CFR Part 820 and/or ISO 13485 requirementsExperience with CAPA, NCR, root cause analysis, risk management, and validation activitiesExperience supporting internal, customer, and regulatory auditsStrong analytical, problem-solving, organizational, and communication skillsStrong technical writing and documentation skillsProficiency with Microsoft Office applicationsPreferred QualificationsMedical device industry experienceExperience with EU MDR, MDSAP, and other international regulatory standardsKnowledge of ISO 14971 and medical device risk managementExperience with statistical software such as Minitab or JMPExperience with software validation and 21 CFR Part 11 complianceASQ certifications (CQE, CQA, CBA) and/or Six Sigma Green Belt or Black Belt certificationExperience with electronic Quality Management Systems (eQMS)Ability to manage multiple projects and priorities in a regulated environmentWhat We're Looking For: The ideal candidate is a proactive, detail-oriented quality professional who enjoys solving complex problems, collaborating across functions, and driving continuous improvement. Success in this role requires strong technical expertise, sound judgement, and a commitment to maintaining the highest standards of product quality and regulatory compliance.