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Quality Assurance Engineer II

1 month ago

Montreal, Quebec, Canada Boston Scientific Full time

About the Role:

The Design Quality Assurance Engineer II is responsible for providing quality engineering support to new product development projects and sustaining projects for current products on the market. This includes developing, establishing, and maintaining quality-engineering methodologies, systems, and practices that meet Boston Scientific, customer, and regulatory requirements.

Key Responsibilities:

  • Develops understanding of Design Controls, Risk Management, and Usability for Medical Devices.
  • Provides quality and compliance input to project teams for project decisions and deliverables.
  • Collaborates with teams to identify and implement effective controls to support development or maintenance of products to meet internal and external requirements.
  • Supports internal and external regulatory audits as required.

Requirements:

  • Bachelor's degree in mechanical, electrical, or biomedical engineering, or equivalent.
  • 3+ years of work experience relating to quality assurance in a highly regulated industry.
  • 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.