Senior Quality Engineer

Senior Quality EngineerSeeking a Senior Quality Engineer with strong MDR remediation and medical device manufacturing quality experience to support compliance, validation, and risk management activities for regulated product families. Roles and responsibilities include:Support MDR remediation and manufacturing quality assurance activitiesDevelop and maintain PFMEAs, Control Plans, and risk management documentationConduct First Article Inspections (FAIs), dimensional verification, and packaging evaluationsPerform process validation activities including IQ, OQ, PQ, and test method validationsConduct production floor assessments and process observations to support risk evaluationsCollaborate with Manufacturing, Quality, Warehouse, Planning, and Product Engineering teamsReview and approve manufacturing change orders and MDR-related updatesSupport labeling verification, packaging testing, and technical documentation updatesMaintain documentation and change records within Agile PLMProcess validation and test method validation experiencePFMEA, Control Plan, and risk management expertiseExperience with FAIs, dimensional verification, and manufacturing changesKnowledge of FDA 21 CFR Part 820 and EU MDR (2017/745)Familiarity with ISO 13485, ISO 14971, and IEC 60601Experience with change control and medical device quality systemsEducation and experience:Bachelor's degree in Engineering or related discipline4+ years of relevant experience (MDR experience highly preferred)DOE/Minitab experienceComputer System Validation (CSV)SOP developmentAgile PLM experiencePackaging validation and fit testing