Quality Engineer 3

Overview In this role, you provide advanced quality engineering support across the medical device lifecycle and lead cross-functional quality initiatives. You drive investigations, validations, risk management, and continuous improvement while mentoring junior engineers. You’ll support design transfer, production readiness, and ensure compliance with regulations and Hologic’s QMS. The position offers impact on product quality and patient outcomes within a collaborative, regulatory-focused environment. You will work closely with diverse teams to enable healthy, scalable product delivery and ongoing quality excellence. ResponsibilitiesLead Nonconforming Event (NCE) investigations with risk assessment, root cause analysis, impact evaluation, and timely disposition, ensuring regulatory and QMS complianceAnalyze quality metrics (NCEs, compliance metrics, management reviews, product quality indicators) to drive corrective actions for unfavorable trendsDevelop, maintain, and update PFMEAs across the product lifecycle, aligning with ISO 14971 during design transfer and productionLead CAPA activities with effective root cause analysis and sustainable corrective actionsSupport New Product Introduction (NPI) and product transfers by facilitating design transfers to production and across sitesAuthor, review, and approve technical reports and documentation for IQ/OQ/PQ validationsDevelop, review, and approve quality plans to ensure product and process complianceContribute to Operational Excellence using lean principles and tools (Six Sigma, SPC, DOE) to improve process capability and performanceMentor and guide junior quality engineers to foster ownership and continuous improvementEnsure adherence to policies, PPE, SOPs, QMSR, ISO standards and Good Documentation PracticesParticipate in training and sustainability initiatives and promote a collaborative, inclusive culture Key requirements7+ years in the medical device quality fieldASQ Certified Quality Engineer (CQE) and/or Six Sigma certification preferredStrong knowledge of ISO 13485, FDA regulations, EU MDR/IVDR, and cGMPExperience in risk management (ISO 14971, PFMEA) and design transferProficiency in Six Sigma, SPC, DOE, and data analysis for process improvementProven experience with root cause investigations, NCE management, and CAPAStrong technical writing and communication skills for validations and compliance documentationExperience with Quality Management Systems, enterprise systems, and quality metricsLeadership and cross-functional collaboration abilitiesleadershipmentorshipcross-functional collaborationISO 13485FDA regulationsEU MDR/IVDR