Senior Quality Engineer

Senior Quality EngineerThe Senior Quality Engineer is responsible for governance, optimization, lifecycle support, and continuous improvement of Foundation Medicine's electronic Quality Management System (eQMS), including Veeva Vault Quality. The role serves as a Quality Systems subject matter expert, partnering with Quality process owners, IT, Product, and business stakeholders to ensure compliant, scalable, and effective digital quality operations. The position supports Quality Systems processes including CAPA, nonconformance, change control, document control, training, audit management, risk management, and Management Review.Regular onsite work at a designated FMI location is an essential function of this role.The Senior Quality Engineer - Digital Quality Systems & eQMS will play a critical role in governing, optimizing, and advancing Foundation Medicine's electronic Quality Management System (eQMS), including Veeva Vault Quality. As a key Quality Systems subject matter expert, this role partners across Quality, Technology, Product, and business functions to ensure compliant, efficient, and scalable digital quality operations. The position supports and enhances core quality processes -including CAPA, nonconformance, change control, document control, training, audit management, risk management, and Management Review - while driving system improvements, data-driven insights, and continuous process optimization. Through a combination of technical expertise, quality systems knowledge, and cross-functional collaboration, the Senior Quality Engineer helps strengthen inspection readiness, advance digital transformation initiatives, and support Foundation Medicine's mission of delivering high-quality products and services that improve patient outcomes.Key Responsibilities:EQMS Governance & Digital Quality Systems Serve as Quality business lead and SME for Veeva Vault QualityProvide governance and lifecycle support for the eQMSPartner with Technology, Digital Solutions, vendors, and process ownersTranslate compliance and process requirements into system requirementsSupport UAT, CSA/CSV, validation, deployment readiness and change impact assessmentsMaintain system documentation and validation recordsSupport integrations between enterprise systemsQuality System Process Enablement Support CAPA, nonconformance, change control, document control, training, audit management, risk management, and Management Review.Develop procedures, work instructions, training materials, and governance documentation.Support issue investigation and resolution related to eQMS processes.Support Quality Improvement Plans.Support regulatory inspections and audits through retrieval of records and evidence.Metrics and Continuous Improvement Develop dashboards and metrics.Support Quality Management Review.Analyze trends and recommend improvements.Drive digital quality system adoption and process optimization.Assist with reporting Key Performance Indicators (KPIs).Perform periodic trending of CAPAs to identify systemic issues, Action plan approvals, Action Task due dates, and root cause failure modes.Be responsible for compliance with applicable Corporate and Divisional Policies and procedures.Other duties as assigned.Comply with FMI's attendance policiesQualifications:Basic Qualifications:Bachelor's degree in Quality, Life Sciences, Computer Systems, Information Systems, Operations or equivalent years of experience in technical or engineering discipline5+ years of related professional experience in Quality Assurance, Quality Systems, eQMS administrative support or a related regulated environmentPreferred Qualifications:5+ years of related professional experience in Quality Assurance, Quality Systems, eQMS administrative support or a related regulated environmentExperience supporting electronic Quality Management Systems including governance, validation, reporting, lifecycle management or configuration supportVeeva Vault Quality experience preferred.Experience with MasterControl, TrackWise, or equivalent eQMS platforms.Experience with system implementation, validation, release management, and integrations.Knowledge of CSA/CSV and 21 CFR Part 11.Dashboard and metric reporting experience.Lean Six Sigma and ASQ certifications.Experience operating under FDA QMSR, ISO 13485, ISO 15189, CLIA, CAP, and GxP environments.Knowledge of Root Cause AnalysisDemonstrated Technical Writing Skills/TrainingUnderstanding of HIPAA and the importance of patient data privacyCommitment to reflect FMI's values: Integrity, Courage, and PassionThe expected salary range for this position based on the primary location of Boston, MA is $101,200 – $126,500 per year. The salary range is commensurate with Foundation Medicines compensation practice and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for Foundation Medicine's benefits.