Auditor, Medical Devices - Full-Time

Medical Device Auditor - Full-time - Remote

Intertek, a leading provider of quality and safety solutions to many of the world’s top-recognized brands and companies, is actively seeking a Medical Device Auditor to join our Business Assurance Team remotely.   This is a fantastic opportunity to grow a versatile career in 3rd party Medical Device Auditing. 

Intertek's Business Assurance team goes beyond testing, inspection and certification to look at the underlying elements that make a company and its products successful. Our assurance solutions provide confidence and total peace of mind that a client's operating procedures, systems and people are functioning properly to provide a competitive advantage in the marketplace.

What are we looking for?

The Auditor, Medical Devices will support the Business Assurance business by 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. The Auditor is the primary interface with the client before and during the process of all auditing activities. Additionally, the Auditor will help train low-graded Auditors through witness audits, technical support, and education of both client and sales force as needed.  

This will be a travel-based position, with extensive travel to client sites required. Candidate must be comfortable traveling 3 to 5 nights per week.  

Salary & Benefits Information

In addition to competitive compensation packages, when working with Intertek you can expect benefits including medical, dental, vision, life, disability, 401(k) with company match, generous vacation / sick time (PTO), tuition reimbursement and more. 

What you’ll do:

• 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.

This position outline is a general guideline and does not represent all encompassing details. The position assumes that the incumbent has both the mental and physical requirements to carry out the above defined duties.  

Minimum Requirements & Qualifications:

• 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 a