About the Job
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 robust productsMain responsibilities:
About youEducation and professional Experience
- Quality representative on cross-functional development teams to support creation of design development plans, design requirements, specification development, engineering studies, design verification and validation protocols, ensuring appropriate selection of acceptance criteria and sampling plans.
- 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
- Assist in the development of validation strategies for performance qualifications and process validations for Medical Device and Drug Device Combination products.
- Support test method development and validation activities
- Review and approve of development documentation, e.g., human factors/engineering studies, risk management (per ISO 14971), others for the product design history file
- Oversee assembly process development and design transfer activities to ensure the product design has been appropriately translated into production specifications, as well as launch readiness activities
- Participate in design reviews to ensure potential problems are identified and corrected early in development to minimize impact to broader project scope/ resources/ budget.
- Ensure a simplified approach to Quality Engineering within assigned project teams by promotion of platform approach when feasible, leveraging tools, best practices, and standardization
- Support root cause investigations and implementation of CAPA utilizing Lean and Six Sigma methodologies.
- Support assessment of proposed design and/or process changes, and post launch changes to design intent, support change control and implementation activities as needed
- Support regulatory submissions pre and post launch, authoring relevant sections as needed, and liaise with global regulatory as well as alliance partners for review of submission documentation and IR’s
- Ensure that internal SOPs as well as Sanofi-internal global guidelines and standards are followed, and regulatory requirements are met and maintained, support review and updates to changing regulations
- Participate in industry forums to stay current with industry trends and guidelines
- B.S./M.S. or equivalent degree in mechanical engineering or related scientific discipline
- 6 years experience in functions related to Quality, Engineering, or Development of Medical Devices and/ or Drug Device Combination products
- Strong analytical skills, and ability to understand complex problems and propose solutions
- Ability to communicate technical content in an efficient manner, verbally and with technical writing skills
- Ability to develop technical presentations and communicate effectively
- 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 team objectives
- General 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
- Product and process design methodology (Six Sigma, DFM, DFA) knowledge a plus
- Certified Quality Engineer and Six Sigma Belt a plus
- Business fluent (written and oral) in English is required, German or French is a plus