Senior Quality Engineer

Foundation Medicine, Inc.

Senior Quality Engineer

• 400 Summer Street, Boston, Massachusetts, United States
• Full Time

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. 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 Medicines 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 Medicines 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 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.
  • Assist with reporting Key Performance Indictors (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 policies

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
• Experience supporting electronic Quality Management Systems including governance, validation, reporting, lifecycle management or configuration support
• Veeva Vault Quality experience preferred.
• Experience with Master Control, Track Wise, 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 FMIs values:
  Integrity, Courage, and Passion

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…