Sanofi Group Manager Quality Software, Medical Device in Cambridge (U.S.), Massachusetts
Manager Quality Software, Medical Device
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and Genzyme.
At Sanofi US, we are committed to the growth of our people, connected in purpose by career, life and health.
Headquartered in Bridgewater, NJ, Sanofi US is part of a leading global healthcare company dedicated to discovering, developing and distributing therapeutic solutions focused on patients’ needs.
Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and Genzyme.
Sanofi US employs approximately 17,000 people across the country all dedicated to protecting health, enhancing life and responding to the hopes and potential healthcare needs of seven billion people around the world.
Commitment is our Strength. Ready to grow together?
Sanofi US endeavors to make our career center accessible to any and all users. If you are experiencing difficulty and need assistance applying online, please call 1-800-207-8049 Option 7, then Option 3.
JOB TITLE - Manager Software Engineer
Provide leadership, guidance, and oversight of the company’s quality system elements and facilitate communication and coordination among project teams and between project teams, functional departments, senior staff and the steering committees.
Leads the Software Engineering organization responsible for developing software medical devices. Supports Lifecycle Management and New Product Development teams, utilizing Common Practices, Methodologies, Processes/Tools.
Manages the development processes and tools for software development in compliance to the FDA software validation guidelines, as well as the IEC 62304 standards for software development. Ensures the software development processes are followed during the development programs to drive continuous improvement in software quality.
Guides team leads to prepare plans, estimates for software deliverables in projects.Delivers critical, timely communications to the leadership on software development and delivery.
Identifies and implements continuous improvements for the software department on multiple axes (Products, Technologies, Processes, Tools, Methods, and Functional Competencies).
Manages the hiring, staffing and maintenance of a diverse and effective software development group.
Participate in the evaluation of technology opportunities which can result in new business models, products or technological advantage.Provides software technical support to other company and corporate groups as required in assigned areas of responsibility. Complete diligence on potential product transfers or development requirements for products or concepts transferred from other potential sources.
Directs team’s responsibilities include Software platform strategy, Software architecture, Detailed design (Products, test fixtures, development tools), Connectivity / Security / Privacy / Interoperability, Software DfX (Reliability / Serviceability / Manufacturability) and IT / R&D collaboration on Connectivity Platforms / Infrastructure / Cybersecurity.
Develops workforce plan to execute on current and future business strategies, inclusive of external workforce augmentation. This will include managing strategic external partnerships for targeted projects / capacity enhancement. This position will be responsible for identifying, evaluating, selecting, contracting, and financially managing partnerships to successfully execute targeted projects.
Acts independently, without day to day direction, on execution of assigned activities.
Perform other work related duties as assigned.
Lead a team of quality engineers to support all design control activities for new product development projects for critical care and ventilators.
Provide strategy and structure for new product quality support including complaint trending, escalation, CAPA investigation and execution, and HHE documentation, as appropriate.
Successfully establish related Quality System procedures that ensure compliance in new product quality and product life cycle management.
Interact with FDA inspectors and auditing body agencies during audits.
Provide guidance and development opportunities for department employees.
The position has direct contribution to meet launch timelines of the medical devices products as well as meeting Sanofi IA Devices requirements and applicable regulatory compliance worldwide.
BS in Computer Science, Systems Engineering, Electrical Engineering, or related Engineering degree MS in related Engineering degree preferred
Relevant experience in Medical devices /Quality Assurance/Control, Manufacturing, and/or Pharmaceutical Research and project management.
10 years experience in new product development focused on quality engineering related activities. Strong preference given to 7 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 cost of quality and risk management to business
Communication skills and sensitivity are key aspects to keep good working relationship with the different sites and global/regional functions of Sanofi
Ability to overcome discrepancies in 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. #LI-GZ
Primary Location: United States-Massachusetts-Cambridge (U.S.)
Job Posting: Aug 25, 2016, 6:25:56 AM
Job Type: Regular
Employee Status: Regular