Auditor, Medical Devices - Full-Time
Intertek · United States
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- Hybrid
- Full-time
- $100,000 / year
- United States
Job highlights
- Audit medical device quality systems.
- Ensure regulatory compliance with standards.
- Extensive travel required nationwide.
- Remote position for US residents.
- Support client certification processes.
About the role
Medical Device Auditor - Full-Time
Intertek is seeking a motivated Medical Device Auditor to join our Business Assurance team. This role supports our accredited certification program by leading and participating in client management system audits. You will be the primary client interface, ensuring their systems meet established standards, client requirements, and regulatory mandates. This is a remote position requiring extensive travel.
Key Responsibilities:
- Lead and/or participate in client management system audits, ensuring compliance with ISO 13485 and other relevant regulatory standards (US, Canada, Japan, Australia, Brazil) and GMP requirements for medical devices, pharmaceuticals, and cosmetics.
- Act as the primary liaison with clients before and during all auditing activities.
- Assist clients with questions related to the audit and certification process.
- Coordinate audit activities with team members and liaise with clients regarding audit progress.
- Review client quality management system documentation and verify/document evidence of compliance and non-compliance.
- Prepare and present audit reports, reviewing findings with coordinators and assessment team members.
- Assist with corrective action requirements and provide technical assistance to the medical team.
- Support continuous improvement initiatives and provide regular status updates to management.
- Train junior auditors through witness audits, technical support, and client/sales force education.
Travel Requirements:
- This is a remote position, but requires extensive travel to client sites, typically 3 to 5 nights per week.
- Primarily domestic travel; some international travel may be required.
- Must possess a valid unrestricted driver’s license.
Minimum Requirements & Qualifications:
- 4-year college/university degree in a science or technical field (e.g., biology, chemistry, engineering, medicine, physics) or equivalent education and experience.
- Minimum of 4+ years of full-time work experience in medical device design, development, testing, or quality assurance/control.
- Minimum of 2+ years in a quality management systems environment (auditing, CAPA, complaints).
- Completed Lead Auditor training (preferably ISO 13485 or relevant regulatory requirements), or willingness to train.
- Strong communication, interpersonal, 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.
- Must reside in and be legally able to work in the United States.
Preferred Requirements & Qualifications:
- Lead Auditor Training with ISO19011 or ISO13485 Certification.
- Experience with regulatory requirements in the EU, US, Australia, Japan, Brazil, and/or Canada.
- Experience implementing/auditing to ISO 13485, ISO 14971, and relevant medical device regulations.
- Specific training/experience in manufacturing processes (e.g., sterilization, machinery, electronic devices, software development).
- Training/experience in quality tools (Kaizen, lean manufacturing).
Key skills/competency:
- Medical Device Auditing
- ISO 13485
- Quality Management Systems
- Regulatory Compliance
- Risk Management
- ISO 14971
- CAPA
- Lead Auditor
- Client Relations
- Technical Writing
Skills & topics
- Medical Device Auditor
- Quality Assurance
- ISO 13485
- Auditing
- Regulatory Compliance
- Medical Devices
- QMS
- Healthcare
- Remote
- Travel
How to get hired
- Tailor your resume: Highlight your 4+ years in medical devices and 2+ years in QMS, emphasizing ISO 13485 and auditing experience.
- Showcase technical skills: Detail your experience with specific medical device types, software, and sterilization methods mentioned in the job description.
- Emphasize travel readiness: Clearly state your willingness and ability to travel extensively (3-5 nights/week) for this remote role.
- Prepare for technical interviews: Be ready to discuss specific audit scenarios, regulatory requirements, and your approach to quality management systems.
- Research Intertek's mission: Understand their commitment to 'Total Quality. Assured.' and how your role contributes to their goals.
Technical preparation
Study ISO 13485 and relevant regulations.,Review medical device types and standards.,Practice auditing scenarios and documentation.,Familiarize with QMS principles and CAPA.
Behavioral questions
Describe a challenging client audit.,How do you manage extensive travel?,How do you ensure objectivity in audits?,How do you handle non-compliance findings?
Frequently asked questions
- What is the work arrangement for the Medical Device Auditor position at Intertek?
- The Medical Device Auditor position at Intertek is a remote role. However, it requires extensive travel to client sites, typically 3 to 5 nights per week. Applicants must reside and be legally able to work in the United States.
- What are the primary responsibilities of a Medical Device Auditor at Intertek?
- As a Medical Device Auditor, you will lead and participate in audits of client management systems to ensure compliance with standards like ISO 13485 and relevant regulatory requirements. You will also serve as the primary client interface, review documentation, prepare reports, and assist with corrective actions.
- What qualifications are essential for the Medical Device Auditor role?
- Essential qualifications include a 4-year degree in a science or technical field, at least 4 years of medical device industry experience, and 2+ years in a quality management systems environment. Completed Lead Auditor training is highly preferred, though training may be provided.
- Does Intertek provide training for the Medical Device Auditor position?
- Yes, Intertek mentions they will train if needed for Lead Auditor training. They also support continuous improvement and may provide technical assistance to the medical team.
- What types of medical devices and standards does the Medical Device Auditor role focus on?
- The role focuses on various medical devices including electronics, software, monitoring devices, dental devices, wound care, cardiovascular and orthopedic implants, and imaging/therapeutic devices. Key standards include ISO 13485, ISO 14971, and GMP regulatory requirements for multiple countries.
- How much travel is expected for the Medical Device Auditor position?
- Extensive travel is a core requirement for this position. You should expect to travel 3 to 5 nights per week, primarily domestically, with potential for some international travel.
- What benefits does Intertek offer to its employees?
- Intertek offers competitive compensation and a comprehensive benefits package including medical, dental, vision, life, disability insurance, 401(k) with company match, generous PTO, and tuition reimbursement.
- How can I apply for the Medical Device Auditor job at Intertek if I need accommodation?