Senior Quality Engineer (eQMS)

Location: Boston, Massachusetts, US; regular onsite work at a designated hirify.global location is required.

Salary: $101,200–$126,500 per year, plus a potential discretionary annual bonus and benefits.

Company

hirify.global develops products and services focused on improving patient outcomes.

What you will do

• Serve as the Quality business lead and subject matter expert for Veeva Vault Quality and govern the electronic Quality Management System.
• Partner with Technology, Digital Solutions, vendors, process owners, Product, and business stakeholders to translate compliance and process requirements into system requirements.
• Support UAT, CSA/CSV, validation, deployment readiness, change impact assessments, lifecycle management, integrations, and validation records.
• Enable CAPA, nonconformance, change control, document control, training, audit management, risk management, and Management Review processes.
• Develop procedures, work instructions, training materials, dashboards, metrics, and governance documentation.
• Analyze quality trends, support inspections and audits, identify systemic issues through CAPA trending, and drive digital quality system adoption and process optimization.

Requirements

• Bachelor’s degree in Quality, Life Sciences, Computer Systems, Information Systems, Operations, or an equivalent technical or engineering background.
• At least 5 years of related professional experience in Quality Assurance, Quality Systems, eQMS administrative support, or a regulated environment.
• Experience supporting electronic Quality Management Systems, including governance, validation, reporting, lifecycle management, or configuration support.
• Experience with system implementation, validation, release management, and integrations.
• Knowledge of CSA/CSV and 21 CFR Part 11.
• Dashboard and metric reporting experience.
• Knowledge of root cause analysis and demonstrated technical writing and training skills.
• Understanding of HIPAA and the importance of patient data privacy.
• Ability to comply with applicable corporate and divisional policies, procedures, and FMI attendance policies.

Nice to have

• Veeva Vault Quality experience.
• Experience with MasterControl, TrackWise, or equivalent eQMS platforms.
• Lean Six Sigma and ASQ certifications.
• Experience operating under FDA QMSR, ISO 13485, ISO 15189, CLIA, CAP, and GxP environments.

Culture & Benefits

• Benefits are available for the position.
• A discretionary annual bonus may be available based on individual and company performance.
• Work is governed by FMI’s values of Integrity, Courage, and Passion.
• Regular onsite attendance is required.