Senior Quality Assurance Specialist

4 days ago


Ottawa, Ontario, Canada Boston Scientific Full time
Job Description

We are seeking a highly skilled Senior Quality Assurance Specialist to join our team in the medical device industry.

About the Role:

This is an exciting opportunity for a quality assurance professional to drive improvement in patient outcomes by ensuring compliance and product quality. You will work closely with internal stakeholders to obtain relevant information required to investigate quality events and liaise effectively between external service providers to drive quality events to resolution.

Your Responsibilities Will Include:

  • Tracking and trending service provider performance to establish thresholds for action.
  • Dispositioning raw materials.
  • Investigating quality events and collaborating with internal stakeholders to resolve issues.
  • Liaising with external service providers to drive quality events to resolution.
  • Aiding in the development of quality documentation, including manuals, policies, procedures, work instructions, and forms.
  • Supporting internal and external regulatory audits.
  • Other duties as assigned.

Required Qualifications:

  • 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%.

Preferred Qualifications:

  • Excellent communication and interpersonal skills.
  • Highly organized with strong attention to detail.
  • Effective time-management skills.
  • Critical thinking.
  • Resourcefulness.

Salary Range:

$120,000 - $160,000 per year, depending on experience.



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