Job Title:
Senior Design Assurance Engineer
About the Role
This is a senior role as part of our cross-functional team for design and development of sterile medical devices. The successful candidate will be responsible for QA technical and compliance expertise, ensuring all activities comply with regulatory requirements such as ISO 13485, CFR 820.
Responsibilities
* Compliance with Medical Policies and Procedures and applicable Regulatory Requirements
* Identifying user requirements into design requirements, identifying critical design features and components
* Generating risk management documents and associated quality documents reports etc.
* Design verification, validation test method validation activities associated with product development activities. Work effectively with R&D Manufacturing Engineering to translate design requirements into manufacturing requirements including the implementation of production process monitoring activities.
Perequisites include a Bachelor's Degree in an engineering science related field plus at least four years experience in QA Quality System or regulatory experience within the medical industry Ideally candidates should have one year prior experience working on product design developments.