Senior Quality Engineer

Role: Senior Quality Engineer specializing in digital quality systems and eQMS governance within a regulated biopharma environment. Primary objectives include managing and optimizing Foundation Medicine's electronic QMS, including Veeva Vault Quality, ensuring compliance, system validation, and continuous process improvement. Responsibilities encompass serving as a SME for Veeva Vault, supporting core quality processes (CAPA, nonconformance, change control, audit management), developing procedures and training, and driving digital transformation efforts. The role also involves metrics development, trend analysis, and supporting regulatory inspections. Qualifications: Bachelor’s degree in Life Sciences, Quality, or related field; 5+ years in Quality Assurance, Quality Systems, or regulated environments; experience with electronic QMS platforms like Veeva Vault, MasterControl, or TrackWise; familiarity with validation, CSV, 21 CFR Part 11, and GxP standards. Preferred skills include Lean Six Sigma, ASQ certifications, and knowledge of compliance frameworks such as FDA QMSR, ISO standards, and HIPAA. The position requires regular onsite work in Boston, MA, with an emphasis on cross-functional collaboration across Quality, IT, and Business units to support high-quality, compliant operations aligned with patient outcomes.