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Design Quality Assurance Specialist
3 weeks ago
We are seeking a highly skilled Design Assurance Engineer to join our team. As a key member of our group, you will play a vital role in ensuring the performance and safety of our structural heart devices.
In this exciting opportunity, you will lead strategies for risk management, test method validations, design verification and shelf-life protocols/reports. You will also be responsible for keeping abreast of industry best practices with respect to product design, maintaining expert knowledge of developments in regulatory compliance requirements for product design, development, transfer and commercialisation activities.
Key Responsibilities:- Lead strategies for risk management, test method validations, design verification and shelf-life protocols/reports.
- Maintain expert knowledge of developments in regulatory compliance requirements for product design, development, transfer and commercialisation activities.
- Collaborate with cross-functional teams to design protocols ensuring new products/product changes are adequately evaluated/tested with respect to standard requirements.
- Provide quality input into new product development, process improvements and change control.
- Advanced degree in Engineering or relevant discipline.
- Minimum 4 years' experience in a highly regulated industry, preferably medical devices.
- Dynamic team player and leader with excellent communication and ability to influence.
- Flexibility to travel (less than 10% of time desirable).
We offer a competitive salary and flexible benefits package. A commitment to our employees' lives is at the core of our values. We recognize their contributions, share in the success they help create, and provide a wide range of benefits, resources and competitive compensation plans designed to support them at every career and life stage.