Hiring: Senior Quality Engineer In Vitro Diagnostics Company: Sanofi Location: Cambridge, MA Job Posted Time: 2026-09-10 11:48:25 Target Skills & Keywords : R, Regulatory Compliance, Risk Management, Root Cause Analysis About the job Experience: •Applied hands-on capability in assay development and validation •Laboratory quality systems implementation and management •Clinical and performance study support •Direct experience with diagnostic, biomarker, and patient selection assays and companion diagnostic programs •Proven track record building or transforming QMS in developing organization Required Skills: •Supplier & Partner Quality: Conduct supplier qualification, audits, and monitoring, and oversee the quality aspects of IVD development, validation, patient testing, and diagnostic activities performed by third parties. •Post-Market Quality & Continuous Improvement: Establish and manage nonconformance, deviation, CAPA, complaint handling, and vigilance reporting systems. Define and implement post-market performance follow-up (PMPF) strategies. Drive continuous improvement through data-driven quality metrics. •Cross-Functional Collaboration: Work closely with IVD development teams, Regulatory Affairs, Clinical, and Laboratory Operations. Balance scientific understanding with quality rigor and business objectives to support IVD commercialization and lifecycle management Qualifications: •Bachelor’s degree in engineering, Biomedical Engineering, Biochemistry, Molecular Biology, Analytical Chemistry, or any field •10+ years in quality management within IVD or closely related diagnostic fields. •Advanced degree (MS/PhD) •Strong expertise in ISO 18113 series, ISO 15189, and CLSI guideline •Knowledge of IEC 62304 (software lifecycle) and IEC 62366-1 (usability engineering) for IVD products with software/SaMD components •Understanding of ISO 14971 risk management principles applied to IVD devices •Demonstrated experience with design controls and DHF/Technical File management for IVD devices •Applied hands-on capability in analytical performance studies (precision, accuracy, linearity, interference, reference interval studies) •Knowledge of assay development lifecycle and validation requirements •Proficiency in risk management tools and methodologies (FMEA, FTA, risk-benefit analysis) Compensation: •$133,500 - $192,833 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!