Medical Device Quality Assurance Auditor

2 months ago

Mississauga, Ontario, Canada Intertek Full time

About Intertek

Intertek is a global leader in quality assurance and testing, dedicated to exceeding customer expectations and fostering a culture of total quality assurance. We strive to make the world a better, safer, and more sustainable place for everyone.

Role: Medical Device Quality Assurance Auditor

As a Medical Device Quality Assurance Auditor, you will play a vital role in evaluating client management systems within the medical device industry. Your responsibilities will encompass conducting comprehensive audits to ensure compliance with industry standards and regulatory requirements.

Responsibilities:

  • Conduct meticulous audits of client management systems, verifying adherence to ISO standards and relevant regulatory guidelines.
  • Provide expert guidance and support to clients regarding audit processes and certification procedures.
  • Prepare detailed audit reports, effectively communicating findings and recommendations to assessment team members.
  • Contribute technical expertise to the medical device team, actively participating in continuous improvement initiatives.

Requirements:

  • A bachelor's degree in a relevant field or equivalent professional experience.
  • Minimum of four years of proven experience within the medical device industry.
  • Exceptional communication and interpersonal skills, enabling clear and concise interactions with clients and colleagues.
  • Ability to travel extensively, both domestically and internationally, as required by client needs.

Preferred Qualifications:

  • Experience in auditing management systems, demonstrating a thorough understanding of audit methodologies.
  • In-depth knowledge of regulatory requirements for medical devices across various countries.
  • Training and certification in ISO standards and quality management systems.
  • Broad experience with a diverse range of medical devices.

Physical Requirements:

  • Ability to ascend/descend ladders, maintain prolonged standing, and lift/carry objects as needed.
  • Strong communication and visual acuity skills are essential for effective performance.

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