Johnson & Johnson Careers
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Senior Design Assurance Engineer
Requisition ID: 1805624073W
KEY RESPONSIBILITES • Responsible for compliance of product development, risk management and post market activities with Cerenovus Policies and Procedures and applicable International Regulations. • Work as part of product development team in identifying and translating user requirements into design requirements, identifying critical design features and components. • Complete design verification, design validation and test method validation activities associated with product development and implementing design/process changes. • Work with R&D and manufacturing engineering in translating design requirements into manufacturing requirements, including the development of manufacturing test methods and implementing production monitoring and controls. • Resolve project issues by working with team members, suppliers, and others as appropriate. Apply thorough, systematic problem-solving methodologies in identifying, prioritising, communicating, and resolving quality issues. • Monitor compliance with Cerenovus policies, procedures and applicable regulatory requirements, identifying and implementing process and system improvements. • Leads and/or facilitates compliance and improvement activities associated with the Cerenovus quality system (e.g. CAPA). • Demonstrate an ability to apply, recommend and/or create quality tools and apply them effectively to a variety of business situations related to product development, and post market activities.
Minimum Bachelor's Degree in Engineering, Science or related technical field, and a 3 years minimum QA, Quality System or regulatory experience in the medical industry a prerequisite. The successful candidate will need a strong technical aptitude with an excellent understanding of their subject matter. Be highly motivated and an enthusiastic self-starter with the ability to work under own initiative and as a team player.
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