[Hiring] Auditor, Medical Devices @Intertek

Role Description

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. This is a remote position; however, applicants must reside in and be able to legally work in the United States.

Qualifications

• 4 year college/university degree in a science or technical field 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.
• A minimum of 2+ years in a quality management systems environment.
• Completed Lead Auditor training for any standard (preferably ISO 13485).
• 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.
• Possess a valid unrestricted driver’s license.

Requirements

• Audit client management systems for compliance with established 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.
• Verify and document evidence of compliance and non-compliance.
• Prepare audit report.
• Review audit results with coordinator and other assessment team members.
• 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.

Benefits

• Competitive compensation packages.
• Medical, dental, vision, life, and disability insurance.
• 401(k) with company match.
• Generous vacation/sick time (PTO).
• Tuition reimbursement.

Physical Requirements

• Ascend or descend ladders, stairs, ramps, and the like.
• Stand for sustained periods of time.
• Walk to accomplish tasks and move from one work location to another.
• Communicate well, conveying detailed accurate information & instructions.
• Hear well, perceiving sounds with or without correction.
• Exert up to 10 pounds of force occasionally.
• Have close visual acuity for activities such as preparing & analyzing data.