Senior Quality Assurance Analyst

  • Change Healthcare
  • Richmond, British Columbia, Canada
  • Aug 06, 2022

Job Description

Overview of Position

The Senior Quality Assurance and Regulatory Analyst role at Change Healthcare Canada Company supports the relevant activities to ensure that the Company's products and business processes comply with relevant medical device regulations.

What will be my duties and responsibilities in this job?
  • Ensure that the Company's Quality System is compliant with the relevant medical device regulations in Canada, United States, Europe and Australia (and other markets the company decides to enter)
  • Mange Supplier Management Program to ensure that subject 3rd
    parties are meeting all relevant requirements, and comply with CHC
    qualification criteria
  • Provides subject matter expertise, interpretations, and training on applicable medical device regulations
  • Provide necessary support for Quality Audits where necessary including
    internal audits, supplier audits, and external audits
  • Conducts medical device regulatory requirements research in the jurisdictions in which IWCS markets and plans to market its products
  • Provides summaries of the updated regulatory requirements landscape and providing access to associated current regulations and standards
  • Provides internal training on the relevant governing standards and regulations
  • Proactively make recommendations and improves relevant quality assurance and regulatory affairs processes and procedures


What are the requirements needed for this position?
  • Bachelor's degree in computer science or Computer Engineering or related discipline
  • Minimum 5 years of ISO 13485 quality systems and regulatory affairs experience in medical device industry, or equivalent
  • Experience in medical device development industry (software medical device experience preferred)
  • Working knowledge of medical device regulations in Canada, United States, European Union, UK, Australia
  • Experience/Background in Quality Management, Regulatory Affairs, or Operations Management


What other skills/experience would be helpful to have?
  • Other related education by training or by work experience RAPS certification preferred
  • Ability to prioritize, multi-task and perform in a deadline-oriented environment
  • Proactive, collaborative, and self-motivated and team player
  • Able to interact constructively with other departments, internal and external agencies, Notified body, auditors


What are the working conditions and physical requirements of this job?
General office duties

How much should I expect to travel?

Up to 10%. Employees in roles that require travel will need to be able to qualify for a company credit card or be able to use their own personal credit card for travel expenses and submit for reimbursement.

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Join our team today where we are creating a better coordinated, increasingly collaborative, and more efficient healthcare system!

Some of our positions require employees to be onsite at a Change Healthcare facility or a Client site, including Medical Facilities. Depending on the site's health and safety guidelines, you may be required to have medical screenings or vaccinations to meet site requirements, which may include Covid-19 vaccination and/or testing. Further details and requirements will be confirmed during the interview process.