Quality Engineer Needed - Must already be located in Boston

Location: South Boston,MA (Hybrid)

Quality Engineer

This position will be responsible for supporting the Quality Information Systems Management (QISM) group, working closely with operational functions and other business and QA groups to facilitate regulatory/data integrity assessments, change control review requirements gathering, design, and system validation. This role will perform quality oversight functions and take quality ownership for all related computerized system projects with particular focus on Manufacturing and Analytical Laboratory systems.

Quality Engineer Responsibilities:

• Proficient with Computerized systems on the Enterprise Level, ServiceNow, QMS, ERP, Veeva EDC, Compass, RIM, Data analytics platforms, Manufacturing Systems, and Lab Systems and provide Quality oversight on the related system projects.
• Take Quality ownership, participate in cross-functional team discussions, provide quality guidance/decisions for the projects that include New implementation, Enhancements, Quarterly releases, Periodic reviews, review and approve Quality events (deviations & CAPS), etc.
• Participate and Drive System Assessments, review and approve the project deliverables, including plan, test scripts, execution and its outcome, reports, and traceability.
• Participate and drive the discussions on issues to the resolutions, adhering to quality compliance.
• Sound knowledge of and Embrace Data Integrity integral to the system projects.
• Should possess good communication skills and fit well as a team player.
• Highlight any identified quality risks and present possible mitigation options to the project team, and keep informed of the quality management.
• Perform, evaluate, and communicate thorough quality assurance at every stage of systems development/implementation

Job Requirements:

• Bachelor's degree in IT or Computer Science
• 6-10 years of proven experience in computerized systems, Enterprise Level and Lab systems validation/quality capacity
• Familiarization with ITIL/GAMP5 Validation Lifecycle
• Proven analytical abilities
• Practical experience generating process documentation and reports
• Excellent communicator with the ability to translate data into actionable insights
• Hybrid role: 3 days/week onsite in South Boston/Seaport location

Preferred Qualifications:

• Strong working knowledge of relevant computerized systems module, structure design
• Proven capabilities in project and user-testing management
• Proven development of innovative and impactful systems solutions
• Highly proficient technical writing capabilities
• Knowledge of Agile validation lifecycle and methodologies.
• Experience with Veeva VQMS, ServiceNow and Application Lifecycle Management with e-signature (ALM) system is highly desirable.