Medical Device Quality Assurance Specialist
6 days ago
The Validation and Verification Engineer is a critical member of our team responsible for ensuring the quality and reliability of our medical device products.
- Develop and optimize physical test methods and test fixtures to support design verification, validation, and commercialization of new medical devices.
- Draft engineering technical reports, test method work instructions, and procedures related to test method validation.
- Lead and execute test method validation, design verification, and test method transfer in support of product design verification or validation.
- Author design verification protocols to satisfy product design inputs/system requirements and applicable Quality System (QS) and regulatory requirements.
- Manage and track product configurations through design verification and validation.
- Conduct hands-on and simulated testing for design verification and test method developments.
- Perform functional and performance testing of products to ensure specifications are met.
In addition to these responsibilities, the successful candidate will also be required to:
- Identify and report out-of-specification results, data, and atypical events during testing activities.
- Analyse and interpret testing data to inform design improvements and identify areas for process optimization.
Requirements
- Minimum Bachelor's degree in Engineering.
- 3+ years of professional experience in medical devices, pharmaceuticals, or life sciences.
- Relevant experience in developing and qualifying test systems and methods.
- Experience with executing Design Verification and statistical data analysis methods/tools.
Benefits
- Competitive salary and benefits package.
- Ongoing training and development opportunities.
- Collaborative and dynamic work environment.
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