Senior Quality Engineer
$101,200–$126,500 year
On-siteBoston, Massachusetts, United States
Job Summary
Govern and optimize Foundation Medicine's electronic Quality Management System (eQMS), including Veeva Vault Quality, by serving as the primary subject matter expert for governance, lifecycle support, and continuous improvement. Partner with cross-functional teams to translate compliance requirements into system specifications, support UAT, validation, and change impact assessments, and maintain rigorous documentation and validation records. Enable core quality processes such as CAPA, nonconformance, change control, audit management, and risk management by developing procedures, investigating issues, and driving data-driven process optimization through dashboards and KPI reporting. Perform periodic trending of CAPAs to identify systemic root causes and ensure full compliance with FDA QMSR, ISO standards, and GxP regulations. Regular onsite work at a designated FMI location is an essential function of this role.
Required 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
- Regular onsite work at a designated FMI location
- Comply with FMI's attendance policies
Desired Qualifications
- 5+ years of related professional experience in Quality Assurance, Quality Systems, eQMS administrative support or a related regulated environment
- Experience supporting electronic Quality Management Systems including governance, validation, reporting, lifecycle management or configuration support
- Veeva 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 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
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