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Design Assurance Career Profile
Design Assurance
Design Assurance engineers provide quality support to R&D and assist in the scale up and commercialization of product.
Role/Responsibility
- Support risk management activities
- Evaluation of new products, assuring the safety and efficacy of the devices
- Design verification and shelf life protocols / reports
- Qualification and validation activities
- Knowledge of regulatory compliance requirements for product design, development, transfer and commercialization activities
- Adhere to Quality System and Design Control requirements
- Root cause investigations; drive problem solving efforts for quality issues
- Manage the compilation of design verification and shelf life data for regulatory submissions to support product approval and release
- Clearly present information to Regulatory Affairs to minimize Regulatory Agency questions
- Support customer complaint analysis and post market surveillance activities
- Generate and approve change requests
Skill/Experience
- Bachelor's Degree in Engineering or Science related Discipline (Master's Degree desirable)
- A minimum of 2 years experience, with at least 1 years experience in the Medical Device industry
- A minimum of 1 years experience in product & process development