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. We’re looking for somebody with a minimum of 6-10 years of full-time work experience in a medical device related industry. Fluency in written and spoken English and French is a requirement.
This will be a full-time remote/home-based position, with extensive travel to client sites required.
- Audit client management systems for compliance with established standards, client and/or industry requirements, government regulations, and other relevant standards,
- 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 y 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 requested. 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
- In-depth knowledge of auditing Management Systems, demonstrated through a combination of education and experience
- 3+ years of industry experience in a professional capacity Related 3 rd party auditing industry management systems preferred Completed lead auditor training for any standard, but will train if needed Advanced coursework or training in Quality Management Systems Degree in Engineering, Mechanical, Quality, or a related major a plus
- A demonstrated ability to communicate effectively, both oral and written
- Ability to define problems, collect data, establish facts, and draw valid conclusions Ability to document and report findings Ability to exercise effective time management skills in completion of assignments Ability to work well in an environment and react effectively in stressful situations
- Must be willing and able to travel extensively
- Primarily domestic travel International travel may be needed (requires a passport)
- Physical dexterity to perform functions which are inherent to the position Mobility to travel by auto and airplane
Intertek offers a culture motivated, customer-oriented environment where employees can flourish, experience professional fulfillment, and reach their highest potential.