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Medical Device Compliance Auditor

3 months ago

Mississauga, Ontario, Canada Intertek Full time

Position: Medical Device Compliance Auditor

Company: Intertek

The Medical Device Compliance Auditor is essential in evaluating client management frameworks within the medical device sector. Key responsibilities encompass assessing client systems for adherence to industry regulations and standards, aiding clients through certification procedures, compiling audit documentation, and delivering technical guidance. This role necessitates significant travel to client locations, typically requiring 3 to 5 nights away each week.

Key Responsibilities:

  • Evaluate client management frameworks for alignment with ISO standards and regulatory mandates
  • Support clients with inquiries regarding audits and certification processes
  • Compile audit documentation and discuss findings with the assessment team
  • Offer technical support to the medical team and foster continuous improvement efforts

Qualifications:

  • Bachelor's degree in a relevant discipline or equivalent professional experience
  • A minimum of 4 years of experience in the medical device field
  • Excellent communication and interpersonal abilities
  • Willingness to travel extensively, both nationally and internationally

Preferred Skills:

  • Experience in auditing management frameworks
  • Familiarity with regulatory standards for medical devices across different regions
  • Training in ISO standards and quality management frameworks
  • Experience with a diverse array of medical devices

Physical Requirements:

  • Capability to climb ladders, remain standing for extended periods, and lift/carry items
  • Strong communication skills and visual acuity

Intertek stands as a global frontrunner in Quality Assurance, dedicated to surpassing client expectations and fostering a culture of comprehensive quality assurance. We are committed to enhancing the world to be a safer, better, and more sustainable environment for everyone.

We uphold diversity and are an Equal Employment Opportunity Employer.