Quality Engineer

Quality EngineerWe are seeking a Quality Engineer to support manufacturing quality operations in a regulated medical device environment. This role is responsible for ensuring product quality, supporting production activities, and maintaining compliance with ISO 13485 and FDA requirements.The Quality Engineer will play a key role in driving product quality, supporting manufacturing and process transfers, and strengthening the Quality Management System (QMS) through hands-on floor support and structured problem solving.Key ResponsibilitiesProduction Quality SupportSupport in-process inspection, final release, and lot history record reviewLead MRB activities and disposition of nonconforming materialSupport supplier and customer quality issue resolutionMonitor supplier quality performance and corrective actionsReview complaints and returned product investigationsQuality Systems & ComplianceSupport ISO 13485 and FDA 21 CFR Part 820 complianceParticipate in internal and external audits and audit readiness activitiesLead or support CAPA investigations and root cause analysisSupport risk management activities (PFMEA, control plans)Support change control and documentation updatesProcess & Facility Transfer SupportSupport quality oversight of process and facility transfersPartner with engineering and operations on validations and requalification activities (IQ/OQ/PQ)Update inspection methods, control plans, and quality documentation during transfersEnsure process controls, SPC, and quality metrics are implemented and maintainedContinuous ImprovementAnalyze quality trends and support data-driven improvementsImprove inspection methods, sampling plans, and process controlsSupport cross-functional problem solving and operational improvementsQualifications5+ years of quality engineering experience in medical device or regulated manufacturingStrong knowledge of ISO 13485 and FDA 21 CFR Part 820Experience with CAPA, root cause analysis, and audit supportExperience supporting manufacturing operations and production floor quality issuesFamiliarity with SPC, MSA, and statistical tools (Minitab preferred)Experience supporting product or process transfers strongly preferredASQ certification (CQE/CQA) preferredMust be eligible to work in the United States without restriction and without the need for current or future sponsorship.