Quality Assurance Engineer III

1 month ago

Montreal, Quebec, Canada Boston Scientific Full time

About the Role:

The Design Assurance Quality Engineer III plays a critical role in ensuring the quality and compliance of medical devices. This position requires a strong understanding of quality engineering principles, design controls, and product risk management.

Responsibilities:

  • Provide quality and compliance input to project teams for project decisions and deliverables.
  • Support software verification and validation activities for new products.
  • Perform risk evaluation and associated management activities related to product development.
  • Support product cybersecurity assessments.
  • Provide quality and compliance input for post-market product sustaining activities.
  • Apply technical skills to identify, prioritize, communicate, and resolve quality issues.
  • Collaborate with teams to identify and implement effective controls to support development or maintenance of products.
  • Work independently on highly specialized projects with long-range objectives.
  • Build quality into all aspects of work by maintaining compliance to all quality requirements.
  • Support internal and external regulatory audits.

Requirements:

  • BS in Electrical Engineering, Mechanical Engineering, or related degree.
  • 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.

About Boston Scientific:

Boston Scientific is a leader in medical science for over 40 years, committed to solving 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 communities.

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