Medical Auditor Jobs

About The Position

Requirements

• A four-year college or university degree in a science or technical field, or an equivalent combination of relevant education and work experience.
• At least 4 years of full-time work experience in the medical-device or related industry, such as design, development, testing, or quality assurance/quality control.
• At least 2 years of experience in a quality management systems environment, such as auditing, CAPA, complaints, or management review.
• Completed Lead Auditor training for any standard; the employer may provide training if needed.
• Strong communication and interpersonal skills.
• Sound judgment and strong organizational and analytical skills.
• Excellent computer and writing skills.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Effective time-management skills for completing assignments.
• Willingness and ability to travel extensively; travel is primarily domestic, with some international travel potentially required.
• Valid unrestricted driver’s license and ability to operate a motor vehicle for official duties.
• Must reside in and be legally authorized to work in the United States.

Nice To Haves

• Lead Auditor training with ISO 19011 or ISO 13485 certification.
• Experience in third-party auditing or management systems.
• Working knowledge of medical-device and pharmaceutical regulatory requirements in the EU, US, Australia, Japan, Brazil, and/or Canada.
• Experience implementing or auditing to ISO 13485, ISO 14971, and medical-device regulatory requirements.
• Medical-device industry experience with orthopedic implants, active devices, software as a medical device, monitoring devices, IVF and ART devices, or sterilization requirements such as ETO and gamma.
• Training or experience with relevant industry manufacturing processes, such as sterilization, machinery, electrical and electronic devices or components, or software development.
• Training or experience with quality tools such as Kaizen or lean manufacturing.

Responsibilities

• Audit client management systems for compliance with established standards, client and industry requirements, government regulations, and relevant medical-device, pharmaceutical, or cosmetics requirements, including ISO 13485 and applicable regulatory requirements.
• Assist clients with questions about audits and the certification process.
• Serve as a Lead Auditor or as a member of an audit team.
• Travel overnight to worksites and client locations, typically three to five nights per week.
• Coordinate audit activity with team members and liaise with clients about audit activity.
• Review clients’ quality management system documentation.
• Verify and document evidence of compliance and non-compliance.
• Prepare audit reports and review audit results with the coordinator and assessment team members.
• Present audit results to clients and/or a certification board 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 continuous-improvement activities.
• Provide management with updates on work, initiatives, and project status as required.
• Help train lower-graded auditors through witness audits, technical support, and education for clients and the sales force as needed.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• Life insurance
• Disability insurance
• 401(k) with company match
• Generous vacation and sick time (PTO)
• Tuition reimbursement
• Competitive compensation packages