Auditor - Medical Devices (Part Time) Ontario

2 months ago

Mississauga, Ontario, Canada Intertek Full time
Job Summary

We are seeking a highly skilled and experienced Auditor to join our team at Intertek. As an Auditor, you will play a critical role in supporting our Business Assurance business by leading and/or participating as an assessor during all phases of a client's management system, in accordance with our accredited certification program.

Key Responsibilities
  • Audit client management systems for compliance with established standards, client, and/or industry requirements, government regulations, and other relevant standards, specifically ISO 13485.
  • Regulatory requirements for the US, Canada, Japan, Australia, and/or Brazil, and/or GMP regulatory requirements related to the medical device, pharmaceutical and/or cosmetic industry.
  • Assist clients with questions relevant to the audit and/or certification process.
  • Act as Lead Auditor or team member.
  • Coordinate audit activity with team members.
  • Liaison with client regarding audit activity.
  • Review client's quality management system documentation.
  • Verify and document evidence of compliance and non-compliance.
  • Prepare audit report.
  • Review audit results with coordinator and other assessment team members. Make presentations to clients and/or certification board concerning audit results, when required.
  • Assist with corrective action requirements resulting from assessments.
  • Participate in audit meetings.
  • Review audit reports and provide technical assistance to the medical team.
  • Support management in areas of continuous improvement.
  • Provide management with updates on status of work, initiatives, and projects, as required.
Requirements
  • In-depth knowledge of auditing management systems in the medical device industry sector, demonstrated through a combination of education and experience.
  • 4 year college/university degree in a science or technical field (biology or microbiology; chemistry or biochemistry; computer and software technology; electrical, electronic, mechanical or bioengineering; human physiology; medicine; pharmacy; physics or biophysics) or equivalent combination of relevant education and work experience.
  • A minimum of 4+ years of full-time work experience in a medical device or related industry.
  • Completed Lead Auditor training for any standard (preferably ISO 13485), but will train if needed.
  • Training in quality management systems and/or relevant regulatory requirements.
  • Strong communication and interpersonal skills.
  • Sound judgment, organizational, and analytical skills.
  • Excellent computer and writing skills.
  • Ability to define problems, collect data, establish facts, and draw valid conclusions.
  • Ability to exercise effective time management skills in completion of assignments.
  • Must be willing and able to travel extensively. Primarily domestic travel, some international travel may be needed.
Preferred Qualifications
  • Related 3rd party auditing industry management systems experience.
  • Working knowledge of relevant regulatory requirements for medical devices and pharmaceuticals in the EU, US, Australia, Japan, Brazil, and/or Canada.
  • Experience implementing/auditing to ISO 13485, ISO 14971, and medical device, pharmaceutical, and/or cosmetic regulatory requirements.
  • Specific experience/training on processes used in the relevant industry's manufacturing (ex. sterilization). Training/experience in quality tools (Kaizen, lean manufacturing, etc.).
  • Working experience in a wide range of medical devices.
Physical Requirements
  • This role requires the ability to:
  • Ascend or descend ladders, stairs, ramps, and the like, using feet and legs and/or hands and arms. Body agility is emphasized.
  • Stand, for sustained periods of time.
  • Walk, moving on foot to accomplish tasks and to move from one work location to another.
  • Communicate well, thru spoken word, conveying detailed accurate information & instructions to others.
  • Hear well, perceiving sounds with or without correction, including the ability to receive information thru oral communications.
  • Exert up to 10 pounds of force occasionally and/or negligible amounts of force frequently to lift, carry, push, pull or otherwise move objects.
  • Have close visual acuity to perform an activity such as preparing & analyzing data, viewing a computer monitor, reading, report writing, visual inspection, and use of measurement devises.

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