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Medical Device Auditor

2 months ago

Arlington Heights, Illinois, United States Intertek Full time
Job Description

Auditor - Medical Devices

Job Summary:

We are seeking a highly skilled Medical Device Auditor to join our Business Assurance Team. As a Medical Device Auditor, you will be responsible for leading and/or participating as an assessor during all phases of a client's management system, in accordance with the company's 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.
  • Travel will include overnight 3 to 5 days per week, to various worksites and client locations.
  • 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:

  • 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 medical device industry (design, development, testing, quality assurance/quality control).
  • A minimum of 2+ years in a quality management systems environment (auditing, CAPA, complaints, management review)
  • Completed Lead Auditor training for any standard (preferably ISO 13485 and/or relevant regulatory requirements), but will train if needed.
  • 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.
  • Possess a valid unrestricted driver's license and the ability to operate a motor vehicle in the performance of the official duties of the position.
  • This is a remote position; however, applicants must reside in and be able to legally work in the United States.

Preferred Requirements:

  • Lead Auditor Training with (ISO19011 OR ISO13485) Certification
  • 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, machinery, electric and electronic devices or components, software development).
  • Training/experience in quality tools (Kaizen, lean manufacturing, etc.).
  • Working experience in a wide range of medical devices.