Medical Device Compliance Auditor

4 weeks ago


Mississauga, Ontario, Canada Intertek Full time

Position: Medical Device Compliance Auditor

Organization: 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, guiding clients through certification procedures, drafting audit documentation, and offering technical guidance. This role necessitates considerable 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 procedures
  • Draft audit documentation and discuss findings with assessment team members
  • Deliver technical support to the medical team and promote continuous improvement initiatives

Qualifications:

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

Desirable Skills:

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

Physical Demands:

  • 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 creating a safer, better, and more sustainable world for everyone.

We embrace diversity and are an Equal Employment Opportunity Employer.



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