Job Title: Digital Device Quality Expert

Reports to: Digital Quality Lead, Health Solutions

Department Name: Digital Quality Operations

Location Cambridge, Bridgewater

Our mission is to support the Sanofi business units by delivering differentiated services and solutions that help patients, physicians, care takers, payers as well as Sanofi to better take care of patients and provide an improved outcome to the healthcare system. Our services and solutions sit on top of our market leading technology platform which we continue to evolve.

We have recruited top talent in the field of Digital Health to help transform care in Diabetes, Speciality Care and beyond in the areas of Drug+ apps. Our team has released an FDA certified class II medical device titration application. We are gearing up for other software applications across the diabetes and speciality care journey, with external LMR partnerships.

The Device Quality Expert will be accountable for  the Software Quality Engineering, Risk Management and Supplier Control support of Software as Medical Device (SaMD) by leading all cGMP compliance activi-ties, as well as compliance with relevant domestic and international regulations, standards and guide-lines and customer requirements. The position contributes directly to meeting regulatory submission and launch timelines of the software as medical devices products. Furthermore,  Device Quality Expert is responsible for applying quality engineering and risk management principles early on in the product development process and through the lifecycle to support a safe and effective product.

Formal Education And Experience Required:

Minimum:

• BS/M.Sc. or equivalent degree in science or engineering (e.g. software engineering, systems engineering, electrical engineering, or related engineering degree)

• 5+ years experience in medical device product development focused on quality engineering related activities

• 2 – 3 years relevant experience in risk management for medical devices

• Strong experience in software development and medical device life cycle management

• Good knowledge of and experience in performing safety and cybersecurity risk management for medical devices

• Proficient in usage of risk assessment methods, e.g.: Hazard Analysis (PHA), Software Risk Analysis, Fault Tree Analysis (FTA), Failure Modes and Effects Analysis (FMEA)

• Good knowledge of medical device regulations and international standards, e.g.:

• ISO 13485, 21 CFR 820, IEC 62304, ISO 14971, TIR 57, MDR, ISO/TR 80001, IEC TR 80002-1

• Language - Business fluent (written and oral) in English is required. 

Preferred:

• Excellent communication and presentation skills, to inform and persuade both in speaking and in writing

• Ability to learn quickly and self-educate on different technologies/therapies as applicable to medical products and procedures (Self-starter attitude)

• A general understanding of the potential sources of risk providing solutions and how to manage them

• 1 -2 years of supplier management experience preffered

• Ability to enter into highly different cultural and regulatory backgrounds worldwide with ‘diplomatic sensitivity’.

• Experience in Agile development principles and can work with atleast one of the common frameworks

• The ideal applicant will have experience in at least one or more of the following technical domains:

• Medical devices and systems

• Mobile device application architecture and security

• IoT (embedded) devices and systems

• Cloud systems architecture and security

• Large-scale application architecture and security

• Data protection architectures for data at rest and in transit

Relationship Management with Stakeholders, Ensure Quality & Compliance of SaMD Products:

• Represent Digital Device Quality on cross-functional teams in support of SaMD activities, collaboration with the internal and external stakeholders (See item V for list of stakeholders)

• Plan for and provide appropriate Quality & Compliance support for the project and application portfolios of the SaMD Digital Health Technology teams

• Promote quality and compliance throughout the Product life cycle and implement processes, procedures and awareness and training on Quality Management System

• Provide quality engineering support for design and development, and facilitate the application of controls and risk management to ensure that SaMD’s are designed to be safe, effective and in compliance with the applicable regulations worldwide

• Work with cross-functional teams to assist in the development of quality agreements, review and approval of design & development plans, requirements, specification development, engineering studies, design verification protocols and validation protocols, ensuring appropriate selection of acceptance criteria and sampling plans.

• Lead and participate in design reviews

• Provide Quality impact assessment for product changes

• Provide quality input into CAPA and nonconforming product investigations

• Support root cause investigations and implementation of corrective actions

Risk Management:

• Lead all risk management activities according to ISO 14971 and TIR 57

• Plan, prepare and perform risk management activities for medical devices according to project phases following all relevant internal procedures, processes and external requirements for development products.

• Ensure that all hazards, threats and vulnerabilities associated with a medical device are identified, the associated risks are estimated and evaluated and that these risks are controlled; monitors that these risk controls are implemented, verified and validated.

• Maintain a close link to the human factors engineering process to meet the needs and ensure the safety of all users and patients.

Supplier Quality:

• Manage external suppliers throughout the product lifecycle, including evaluating and qualifying suppliers, monitoring supplier performance, auditing supplier's quality management system to applicable regulations and quality standards, providing metrics, and addressing quality and regulatory issues.

• Author and maintain quality agreements

Audits and Inspections:

• Collaborate with Business Product owners, Quality and Digital teams to prepare for regulatory inspections and internal audits, respond to questions and address findings through corrective/preventive action plans to improve compliance and effectiveness of the Quality Management System

Digital Units:

• Digital business units leaders

• Centers of Excelence and Digital Product Owners

• Architecture

• CyberSecurity Expertise

Stakeholders outside of Digital:

• Global Regulatory affairs

• Global Medical Device Quality

• Pharmacovigilace

• Data Privacy Office

• Legal

External Stakeholders:

• Regulatory Agency inspectors

• External auditors

• Suppliers / Service Providers

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.

#GD-SA 
#LI-SA

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.