Quality Assurance Specialist

12 hours ago


Ottawa, Ontario, Canada Boston Scientific Full time
About the Role

We are seeking a Quality Engineer II to join our team in driving the build out of our local management systems to support compliance and product quality. This role brings together a blend of operational/supplier quality with quality systems design.

Responsibilities
  • Track and trend service provider performance to establish thresholds for action.
  • Disposition raw materials.
  • Work with internal stakeholders to obtain relevant information required to investigate quality events.
  • Liaise effectively between external service providers to drive quality events to resolution.
  • Aid in development of quality documentation, including manuals, policies, procedures, work instructions, and forms.
  • Support in internal and external regulatory audits.
Requirements
  • Bachelor's Degree in Science or Engineering or relevant and progressive work experience in lieu of degree (Minimum of 8 years' experience in GMP environment).
  • 1-3 years of relevant work experience in the medical device industry, directly supporting Quality Management Systems and documentation.
  • Knowledge of ISO 13485, MDSAP, ISO 9001, ISO 11607, and/or AIMDD/EU MDR.
  • Ability to travel domestically and/or internationally up to 10%.

The estimated salary for this position is $80,000 - $110,000 per year, depending on qualifications and experience. If you have a strong background in quality assurance and are passionate about driving excellence in product quality, we encourage you to apply.



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