Sanofi Group Quality Software Engineer in Cambridge, Massachusetts
Quality Software Engineer
Lead the development related Quality tasks in multifunctional, international project teams to progress business/project issues or objectives.
Enforce policies and procedures for System Life Cycle control across all automated processes that drive, interface with, and provide data for the Quality System.
Support development of the validation strategy and the validation effort from planning to retirement of software systems and tools including interfaces to and from the system.
Support regulatory and internal audits. Provide subject matter expertise during regulatory and partner inspection.
Provide software quality assurance support in design and development of software solutions, and facilitate the application of controls and risk management by reviewing and approving software change-control requests to assess potential quality system impact.
Ensure that system development projects and changes to existing systems are conducted in compliance with the FDA Quality System Regulation and Medical Device Directives.
Work alongside other validation professionals to gather data, plan activities, and obtain reviews and approvals of documentation including approving documentation with respect to software development lifecycle policies and procedures.
Assist in developing user, functional and technical requirements.
Provide guidance and support to personnel in their validation efforts, to ensure compliance.
Provide GxP-related quality assurance oversight, with an emphasis on software validation.
Track system life cycle deliverables and activities to ensure that regulations, protocols, procedures, and methodologies are followed, and that appropriate and complete documentation is captured and reported to support validation activities.
Represent Quality & Regulatory Compliance and Control on cross-functional teams in support of MED activities.
Advise technical personnel and management on regulatory compliance and interpretation and recommend appropriate corrective actions where needed.
Complete other responsibilities, as assigned.
BS in Computer Science, Systems Engineering, Electrical Engineering, or related Engineering degree
4+ years experience in new product development focused on quality engineering related activities.
MS in related Engineering degree preferred
Relevant experience in Medical devices /Quality Assurance/Control, Manufacturing, and/or Pharmaceutical Research and project management.
5+ years of medical device industry experience
Certified Quality Engineering – ASQ certification preferred (CQE)
Certified Software Quality Engineer – ASQ certification highly preferred (CSQE)
Knowledge of ISO 13485, ISO 14971, and IEC 62304 are highly desirable #LI-SA
Sanofi US Services, Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Sanofi is a global healthcare leader focused on patients' needs, engaged in the research, development, manufacturing and marketing of therapeutic solutions focused on patients’ needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and Sanofi Genzyme.
At Sanofi, our ambition is to be an integrated global healthcare company, focused on patients’ needs. Much more than just a leading pharmaceutical company, Sanofi is committed to transforming scientific innovations into solutions and services that protect health, enhance life, and respond to the needs of the 7 billion people in the world. We trust our ambition to guide and inspire us as we work to create a future with optimal health and wellness for everyone.
Sanofi is a global healthcare leader focused on patients' needs, engaged in the research, development, manufacturing and marketing of therapeutic solutions focused on patients’ needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets and Sanofi Genzyme.