Quality Assurance Engineer III

4 weeks ago

Montreal, Quebec, Canada Boston Scientific Full time

About the Role:

The Design Assurance Quality Engineer III at Boston Scientific 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 BSC, customer, and regulatory requirements.

This role is a hybrid position based out of Montreal, Canada with the expectation to be in the office a minimum of three days per week.

Your Responsibilities Will Include:

  • Providing quality and compliance input to project teams for project decisions and deliverables.
  • Supporting software verification and validation activities for new products.
  • Performing risk evaluation and associated management activities related to product development.
  • Supporting product cybersecurity assessments in conjunction with a cross-functional team.
  • Providing quality and compliance input for post-market product sustaining activities.
  • Applying technical skills to identify, prioritize, communicate, and resolve quality issues.
  • Collaborating within a team to identify and implement effective controls to support development or maintenance of products.
  • Working independently on highly specialized projects with long-range objectives.
  • Maintaining compliance to all quality requirements.
  • Supporting internal and external regulatory audits as required.

Required Qualifications:

  • Bachelor's degree in Electrical Engineering, Mechanical Engineering, or a related field.
  • Minimum of 6 years of medical device engineering experience.
  • In-depth familiarity with FDA, ISO, MDD, EU MDR, and medical device industry quality requirements.
  • 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.
  • Strong communication and presentation skills.
  • High energy problem solver capable of driving items to closure.
  • Ability to collaborate and work on a global team.

Boston Scientific is a leader in medical science, committed to solving the challenges that matter most. Our mission is to advance science for life, transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate.

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