Prinicipal Quality Engineer

Job description

Principal Quality Engineer overseeing all Quality work steam activities for Medical Device and Drug Device Combination product development programs; responsible for ensuring all development activities are carried out in compliance with internal and external regulations (e.g. Design Controls) with fully compliant and auditable design history files; responsible for end-to-end Quality activities to ensure best product Quality

Responsibilities

·  Assure all design and development activities are in compliance with Design Controls and the relevant elements of the Quality System Regulations (21CFR820, ISO13485) for Medical Device and Drug Device Combination products.
·  Work with cross-functional development teams to assist in the development of design development plans, design requirements, specification development, engineering studies, design verification protocols and validation protocols, ensuring appropriate selection of acceptance criteria and sampling plans.
·  Participate in design reviews and provide expert technical Quality input to ensure potential problems are identified and corrected early in development to minimize impact to broader project scope/ resources/ budget.
·  Oversee assembly process development and design transfer activities to ensure that product design has been appropriately translated into production specifications.
·  Assist in the development of validation strategies for performance qualifications and process validations for Medical Device and Drug Device Combination products.
·  Review and approval of development documentation, e.g. for the product design history file.
·  Support/ lead root cause investigations and implementation of corrective actions utilizing Lean and Six Sigma methodologies.
·  Provide expert Quality input for proposed design and/or process changes
·  Provide expert Quality input and participate in supplier, customer, internal and/ or regulatory agency audits

Education/Experience

·  BS/M.Sc. or equivalent degree in Engineering or related scientific discipline
·  5 – 7 years in functions related to Quality, Engineering, or Development of Medical Devices and/ or Drug Device Combination products
·  Experience in Software Development and Medical Device Life Cycle Management is a plus

Technical skills & Competencies/Language

·  Demonstrated knowledge in quality and design development systems (e.g. ISO13485, 21 CFR 820)
·  Experience in Medical Devices and/ or Drug Device Combination product development (e.g. ISO11608, ISO10993, ISO60601, ISO11040; ISO14971)
·  Experience in IEC 62304 is a plus
·  Robust process and product design methodology (Six Sigma, DFM, DFA) , Certified Quality Engineer and Six Sigma Belt a plus
·  Analytical skills and ability to understand complex problems and structure into logical streams for resolution
·  Decision making ability
·  Ability to operate in an international, cross-company and cross-functional environment.
·  Communication and inter-personal skills necessary to build trust, confidence, and collaboration toward shared objectives
·  Language - Business fluent (written and oral) in English is required

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.

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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.