Senior Quality Engineer

About The Job

The 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.

Key Responsibilities

• Serve as Quality business lead and SME for Veeva Vault Quality
• Provide governance and lifecycle support for the eQMS
• Partner with Technology, Digital Solutions, vendors, and process owners
• Translate compliance and process requirements into system requirements
• Support UAT, CSA/CSV, validation, deployment readiness and change impact assessments
• Maintain system documentation and validation records
• Support integrations between enterprise systems
• Quality 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
• Aid 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

Qualifications

• Basic Qualifications: Bachelor's degree in Quality, Life Sciences, Computer Systems, Information Systems, Operations or equivalent years of experience in technical or engineering discipline
• 5+ years of related professional experience in Quality Assurance, Quality Systems, eQMS administrative support or a related regulated environment
• Preferred Qualifications: 5+ years of related professional experience in Quality Assurance, Quality Systems, eQMS administrative support or a related regulated environment
• Veeva Vault Quality experience preferred
• Experience supporting electronic Quality Management Systems including governance, validation, reporting, lifecycle management or configuration support
• 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
• Leverage Lean Six Sigma and ASQ certifications
• Knowledge of Root Cause Analysis
• Demonstrated Technical Writing Skills/Training
• Understanding of HIPAA and the importance of patient data privacy
• Commitment to reflect FMI’s values: Integrity, Courage, and Passion

Pay

The 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.