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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 throughout the certification journey, 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 assessment team members
  • Offer technical support to the medical team and facilitate continuous improvement efforts

Qualifications:

  • Bachelor's degree in a relevant discipline or equivalent professional experience
  • At least 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 Demands:

  • Capability to climb ladders, maintain standing positions 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 creating a safer, better, and more sustainable world for everyone.

We embrace diversity and are an Equal Employment Opportunity Employer.