Auditor - Non-Active Medical Devices

Position Summary

To perform conformity assessment, quality management system audits, supplier audits, and technical reviews for manufacturers of non-active medical devices in accordance with applicable regulatory requirements, standards, and certification schemes. The auditor will evaluate compliance with quality management systems, regulatory requirements, and applicable medical device regulations.

Your Tasks:

• Conduct audits of medical device manufacturers, suppliers, and subcontractors for non-active medical devices.
• Assess compliance with:
• ISO 13485 Quality Management Systems
• Applicable Medical Device Regulations and standards
• Risk Management processes (ISO 14971)
• Design, manufacturing, sterilization, packaging, and post-market surveillance processes where applicable.
• Prepare audit plans, conduct on-site and remote audits, and complete audit reports within defined timelines.
• Review quality system documentation, procedures, technical files, and manufacturing records.
• Identify nonconformities and evaluate corrective action plans.
• Participate in witness audits, qualification activities, and technical reviews as required.
• Maintain auditor qualifications and continual professional development.
• Support certification and regulatory assessment activities.
• Communicate effectively with clients and internal stakeholders regarding audit findings and compliance requirements.
• Client management as customer specialist

Your Qualifications:

Education

Bachelor's degree in one of the following disciplines:

• Engineering (Mechanical, Biomedical, Industrial, Manufacturing, Electronics, Materials, Chemical or related disciplines)
• Life Sciences
• Biological Sciences
• Medical Sciences
• Physics, Chemistry, or other relevant scientific disciplines

Experience

Candidates must meet either of the following criteria:

• Minimum 2 - 4years of experience in non-active medical device manufacturing, quality assurance, quality control, regulatory affairs, engineering, production, design, validation, process development, or related functions within a medical device organization.
• Minimum 2 years of experience performing audits, technical reviews, product assessments, or certification activities for non-active medical devices within a Notified Body, Certification Body, Regulatory Authority, or similar conformity assessment organization.

Preferred Experience

Experience with one or more of the following technologies:

• Orthopedic implants
• Surgical instruments
• Wound care products
• Dental products
• Catheters
• Disposable medical devices
• Sterile medical devices
• Ophthalmic products

Required Knowledge

• ISO 13485.
• ISO 14971
• Medical Device Regulations (EU MDR, MDSAP, national regulations)
• CAPA systems
• Design Controls
• Process Validation
• Sterilization Processes
• Cleanroom Manufacturing
• Packaging Validation
• Supplier Quality Management
• Post-Market Surveillance and Vigilance
• Usability Engineering
• Risk Management

Auditor Competencies

• Strong analytical and problem-solving skills.
• Excellent report writing and documentation skills.
• Effective verbal and written communication skills in English.
• Ability to work independently and manage multiple audit assignments.
• Professional conduct and integrity.
• Willingness to travel nationally and internationally for audits.

Additional  Qualification Preferences

The following certifications are advantageous but not mandatory:

• Qualified Lead Auditor in ISO 13485 or equivalent auditing scheme.
• Experience auditing or manufacturing non-active medical devices such as:
• Knowledge of EU MDR 2017/745 and MDSAP program requirements.

Additional certifications in quality management, regulatory affairs, or auditing.