Sanofi Group Senior Quality Engineer in Cambridge, Massachusetts
The Senior Quality Engineer for this role will support Software as Medical Device (SaMD) activities, focusing on the following tasks:
Ensure cGMP and QMS compliance by championing compliance with both internal and customer technical teams. Identify and ensure compliance with relevant domestic and international pharmaceutical and medical device regulations, ISO standards and FDA guidelines
Represent Quality on cross-functional teams in support of MED activities
Provide quality engineering support in design and development, and facilitate the application of design controls and risk management
Assist in developing user, functional and technical requirements
Provide quality engineering support and approval of verification and validation strategies, activities, protocols, reports, etc
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
Provide quality input into CAPA and nonconforming product investigations
Provide quality support during internal/external inspections of MED
BS in Systems Engineering, Electrical Engineering, Mechanical Engineering or related Engineering degree
4+ years of experience in new product development focused on software quality engineering related activities
Medical device industry experience MUST HAVE
MS in related Engineering degree preferred
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
Financial awareness of the cost of quality and risk management to business
Ability to overcome discrepancies in the interpretation of quality requirements without compromises. Ability to talk round and negotiate ‘grey’ areas.
Ability to build up human relationships and a basis of mutual trust between quality and project teams
Ability to enter into highly different cultural and regulatory backgrounds worldwide with ‘diplomatic sensitivity’.
Capability to present the results of the quality assessments to all levels of Local/Regional/Global Management.
Flexibility in approach and ability to adapt to changing circumstances when required.
Excellent team player and team leader, decision making and problem-solving skills
Sanofi 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.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
- Sanofi Group Jobs