Senior Quality Engineer - 253581

We’re seeking an experienced Senior Quality Assurance Engineer to support manufacturing and product lifecycle quality activities within a fast-paced medical device environment. This role will partner cross-functionally with Operations, Engineering, and Regulatory teams to ensure compliance, drive continuous improvement, and support commercial manufacturing readiness.Key Responsibilities:Lead CAPA, nonconformance investigations, and root cause analysisSupport audits, inspection readiness, and quality system complianceOversee supplier quality and incoming inspection activitiesReview and approve IQ/OQ/PQ protocols, reports, and change controlsMaintain Design History Files (DHF) and support PLM activitiesPartner with production teams on GMP compliance and process improvementsQualifications:5+ years of Quality/QA Engineering experience in medical devicesStrong knowledge of ISO 13485, 21 CFR 820, and risk management principlesExperience with CAPA, audits, supplier quality, and validation activitiesElectromechanical, PCB (printed circuit board), and/or sensor experience highly preferredFamiliarity with PLM systems and quality tools/methodologiesBachelor’s degree in Engineering, Life Sciences, or related field