What are the responsibilities and job description for the Quality Engineer position at Marchon Partners?
Position: Quality Engineer/Sr. Engineer, Computerized Systems Quality and Management
Location: Hybrid, minimum 3 days/week onsite in Boston, MA
Duration: 12 month contract with possibility for extensions
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.
KEY RESPONSIBILITIES:
- Proficient with Computerized systems on the Enterprise Level, ServiceNow, QMS, ERP, Veeva EDC, Compass, RIM, Data analytics platforms, Lab Systems, and Manufacturing Systems and provide Quality oversight on the related system projects.
- Take Quality ownership, participate in cross-functional team discussions, provide quality guidance/decisions for projects that include new implementation, enhancements, quarterly releases, periodic reviews, and review/approve Quality events (deviations & CAPAs), etc.
- Participate in and drive system assessments, review and approve project deliverables, including plans, test scripts, execution outcomes, reports, and traceability.
- Participate in and drive discussions on issue resolution while adhering to quality compliance requirements.
- Demonstrate sound knowledge of and commitment to Data Integrity principles within system projects.
- Possess strong communication skills and work effectively as a team player.
- Highlight identified quality risks, present mitigation options to the project team, and keep quality management informed.
- Perform, evaluate, and communicate thorough quality assurance activities at every stage of systems development/implementation.
MINIMUM QUALIFICATIONS:
- Bachelor's degree in IT or Computer Science
- 5 years of proven experience in computerized systems, enterprise-level and laboratory systems validation/quality environments
- Familiarization with ITIL/GAMP5 Validation Lifecycle
- Proven analytical abilities
- Practical experience generating process documentation and reports
- Excellent communication skills with the ability to translate data into actionable insights
PREFERRED QUALIFICATIONS:
- Strong working knowledge of relevant computerized systems modules and structure design
- Proven capabilities in project and user-testing management
- Proven ability to develop 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) systems is highly desirable.