Quality Assurance Engineer

Job content

• Continuously improve the company quality system by analyzing KPIs and data such as complaints, non-conformances, CAPAs etc., reporting trends and providing solutions to any quality and technical issues affecting compliance
• Proactively investigates, identifies, and implements best-in-class Quality Assurance practices in regulated industries
• Be responsible for development, preparation, collation or control of all CSV documentation to deliver continued compliance with ISO13485 standard and FDA / EU Regulations
• Interface directly with IT, Engineering and Vendors to develop CSV strategy
• Provide support for quality system processes and best practices
• Provide Quality compliance expertise and support as required by the organization
• Create or review documents prepared by stakeholder (e.g. plan, protocols, reports, change controls)
• Assist in resolution of deviations/ exceptions during qualification activities
• Oversee and administer document lifecycle management as well as the Document Change Request process
• Perform final approval of documents submitted through the change control process for format, completeness and review
• Handle company Quality Audit process
• Conduct QA-RA intelligence/research to maintain current knowledge base of existing and emerging regulations, standards, or guidance documents and recommend changes to company procedures in response to changes in regulations or standards
• Conduct training on quality assurance concepts and tools to the organization
• Managing the site calibration program, the coordination of calibration activities and associated documentation.
  

• Bachelor of Science in an engineering or applied science discipline
• 2-5 years’ experience in the healthcare industry
• Detailed knowledge of FDA Quality Systems Regulations, ISO 13485, 21 CFR part-11 and other global regulations and standards
• Experience with statistical analysis concepts and techniques
• Advanced personal computing skills and familiarity with a variety of business software packages including Office, Atlassian tools, ERP and able to learn new technologies quickly
  

• Fluent in English (level C1) with minimum B2 level in French