Quality Assurance Lead for Medical Devices

1 week ago


Mississauga, Ontario, Canada Boston Scientific Full time

About the Role:

We are seeking a Quality Assurance Lead to drive quality improvement projects across functions. This position requires leadership skills and expertise in medical device design controls.

Key Responsibilities:

  • Provide quality engineering support for the Design Assurance team.
  • Navigate government regulations and standards, including 21 CFR 820, ISO 13485, and ISO 14971.
  • Develop, modify, and maintain quality system (QMS) requirements.
  • Collaborate with engineering and other functions to ensure quality requirements are met.
  • Collaborate with Research & Development (R&D) Engineers to update Design History Files (DHFs) and meet new requirements.
  • Provide quality and compliance input to project teams for project decisions and deliverables, especially those related to risk.
  • Support internal and external audits as required.

Requirements:

  • Bachelor's degree in engineering required.
  • 4-5 years of medical device experience, or advanced degree with a minimum of 3 years medical device experience.
  • A strong understanding of medical device design controls.
  • Must be a critical thinker and active listener with good time management skills.
  • Self-starter with the ability to quickly learn about new processes.
  • Excellent analytical and communication skills (written and oral).
  • Ability to work effectively within a team and across functions.

Preferred Qualifications:

  • Experience working in a quality role at a medical device company.
  • Experience working with PLM (Windchill) and ERP (MES and/or SAP) software.
  • Experience with quality system integration.
  • Experience with DHF remediation projects.

About Boston Scientific:

Boston Scientific is a leader in medical science for over 40 years, committed to solving challenges that matter most. We are united by a deep caring for human life and strive to advance science for life through innovative medical solutions.

Salary Range:$120,000 - $150,000 per year



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