Digital Quality Systems Lead: eQMS & Compliance

Foundation Medicine; Boston (MA); Hybrid; USD 101,200 - 126,500; Full time

Benefits offered by this job

Discretionary bonus

Benefits

Job summary

Foundation Medicine in Boston, MA is seeking a Senior Quality Engineer for Digital Quality Systems and eQMS to govern, optimize, and advance the company’s electronic quality management system, including Veeva Vault Quality. You will partner with Quality, IT, Product and business teams to ensure compliant, scalable digital quality operations.

The role drives CAPA, nonconformance, change control, document control, training, audit management, risk management, and management review, while delivering

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

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 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

Skills

Veeva Vault Quality

eQMS

CAPA

Change control

Document control

Audit management

Risk management

Quality systems

Validation

CSV/CSA

Root Cause Analysis

Dashboard reporting

Lean Six Sigma

Education

Bachelor's degree in Quality, Life Sciences, Computer Systems, Information Systems, Operations or equivalent

Tools

Veeva Vault Quality

MasterControl

TrackWise

Job description

Foundation Medicine in Boston, MA is seeking a Senior Quality Engineer for Digital Quality Systems and eQMS to govern, optimize, and advance the company’s electronic quality management system, including Veeva Vault Quality. You will partner with Quality, IT, Product and business teams to ensure compliant, scalable digital quality operations.

The role drives CAPA, nonconformance, change control, document control, training, audit management, risk management, and management review, while delivering