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Job Description
As a Design Assurance Specialist, you will be responsible for:
- Supporting the Product Development and Engineering (PD&E) team to ensure that design requirements (design inputs and user needs) comply with internal product development guidelines as well as applicable regulatory standards and requirements.
- Ensuring the rigorous application of risk management principles across all projects, including the analysis of historical data related to similar products (complaints, CAPAs, service parts, etc.).
- Reviewing and approving product-related documentation to ensure that design dossiers comply with current regulatory requirements.
- Coordinating engineering actions arising from the quality system (nonconformities, audit observations, etc.) and ensuring proper follow-up.
- Ensuring the validation of software tools used by the department (Excel spreadsheets, test benches, etc.).
- Maintaining close collaboration with other departments to support the efficient execution of projects and activities.
Required Profile
- Bachelor’s degree in engineering or science, combined with at least three (3) years of relevant experience in a regulated environment, or any equivalent combination of education and experience.
- Proficiency in English at an intermediate to advanced level (4/5).
- Full professional proficiency in French (5/5).
- Knowledge of quality systems.
- Strong attention to detail, autonomy, and a keen interest in the technical aspects of products.
- Excellent analytical skills, critical thinking, and the ability to work effectively as part of a team.
- Knowledge of regulations related to medical product development (an asset).
- Experience in the medical field or in a highly regulated industry (an asset).