Senior Quality Design Assurance Engineer / ingénieur principal en assurance de la qualité

Location: Montreal, QC, Canada About the role

The ideal Senior Design Quality Assurance Engineer will lead new product development and sustaining projects for our cardiovascular products, developing quality-engineering methodologies that meet regulatory and customer requirements. Responsibilities

Apply Design Controls, Risk Management, and Usability for Medical Devices. Provide quality and compliance input to project teams (Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Reviews, V&V, Usability Testing, SW Validation, Process Validation and Labeling). Support post‑market activities such as design changes, NCEP’s, CAPA’s, PIRs, Field Signal Evaluations and Field Actions. Identify, prioritize, communicate and resolve quality issues using systematic problem‑solving methodologies. Collaborate within a team to implement controls that support product development or maintenance to meet internal and external requirements. Build quality into all aspects of work, maintaining compliance to all quality requirements. Support internal and external regulatory audits as required. Other duties as necessary or required by the organization. Required qualifications

Bachelor’s degree in mechanical, electrical, or biomedical engineering, or equivalent. 7+ years of quality assurance experience in a highly regulated industry. Proficient with Microsoft Office Suite. Preferred qualifications

Focus on detailed work with emphasis on accuracy and completeness. Excellent organizational and planning skills; drive results. Strong communication (oral and written) and presentation skills. High energy problem solver capable of driving items to closure. Ability to collaborate and work on a global team. Fluency in English is required; proficiency in French is preferred for this position in Québec. Compensation commensurate with experience and qualifications.

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