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Design Assurance Quality Assurance Specialist

2 months ago

Montreal, Quebec, Canada Boston Scientific Full time

About the Role:

The Design Assurance Quality Assurance Specialist provides quality engineering support to new product development projects and sustaining projects for current products on the market. They will develop, establish, and maintain quality-engineering methodologies, systems, and practices which meet regulatory requirements.

This is a hybrid position with the expectation to be in the office a minimum of three days per week.

Your Responsibilities Will Include:

  • Provide quality and compliance input to project teams for project decisions and deliverables.
  • Support software verification and validation activities for new product.
  • Perform risk evaluation and associated management activities related to product development.
  • Support product cybersecurity assessments in conjunction with a cross-functional team.
  • Provide quality and compliance input for post-market product sustaining activities.
  • Apply technical skills to identify, prioritize, communicate, and resolve quality issues.
  • Collaborate within a team to identify and implement effective controls to support development or maintenance of products.
  • Build quality into all aspects of work by maintaining compliance to all quality requirements.
  • Support internal and external regulatory audits as required.

Required Qualifications:

  • BS in Electrical Engineering, Mechanical Engineering, or related degree.
  • Minimum of 6 years of medical device engineering experience.
  • In-depth familiarity with regulatory requirements associated with product development, design controls, and product risk management.
  • Strong communication and presentation skills.
  • Solid technical writing skills.

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.