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

Description de poste

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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