Senior Quality Assurance Manager

3 days ago

Mississauga, Ontario, Canada Boston Scientific Full time

About the Role

We are seeking a highly skilled Senior Quality Assurance Manager to join our team at Boston Scientific. As a leader in medical science, we are committed to solving the challenges that matter most and advancing science for life.

Key Responsibilities

  • Provide quality engineering support for the design assurance team, ensuring compliance with government regulations and industry standards.
  • Develop, modify, and maintain quality system requirements, collaborating with engineering and other functions to ensure quality requirements are met.
  • Collaborate with research and development engineers to update design history files and meet new requirements.
  • Provide quality and compliance input to project teams for project decisions and deliverables, especially those related to risk.
  • Provide training to affected members of the organization on new or updated quality system requirements.
  • 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.
  • Strong understanding of medical device design controls.
  • Critical thinking and active listening skills, 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 design history file remediation projects.

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