Quality Assurance Engineer

6 days ago

Montreal, Quebec, Canada Boston Scientific Full time

About the Role:

The Design Quality Specialist will provide quality engineering support to new product development projects and sustaining projects for current products on the market. Furthermore, they will develop, establish, and maintain quality-engineering methodologies, systems, and practices which meet business standards, customer, and regulatory requirements.

Your Responsibilities Will Include:

  • Develops understanding of Design Controls, Risk Management, and Usability for Medical Devices.
  • Provide quality and compliance input to project teams for project decisions and deliverables (i.e., Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Reviews, Design V&V, Usability Testing, SW Validation, Process Validation, and Labeling).
  • Provide quality and compliance input for post-market product sustaining activities, such as design changes, NCEPs, CAPAs, PIRs, Field Signals Evaluations, and Field Actions.
  • Applies technical skills including sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Responsible for collaborating within a team to identify and implement effective controls to support development or maintenance of products to meet internal and external requirements.
  • Built quality into all aspects of work by 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.
  • 0-2 years of related work experience.
  • Medical device experience.
  • Competent with use of Microsoft Office Suite.

Preferred Qualifications:

  • Focus on detailed work with emphasis on accuracy and completeness.
  • Excellent organizational and planning skills; drives for 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.

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