My client, a leading notified body, specializes in the certification and compliance of medical devices. They work closely with manufacturers to ensure that their products meet the highest standards of safety and efficacy, maintaining rigorous regulatory oversight to protect public health.
Job Description
My client is seeking an experienced Medical Device Auditor to join their team. The ideal candidate will have a strong background in Quality Management Systems (QMS), sterilization processes, and non-active medical devices, including cardiology implants, ophthalmic devices, and animal tissue-based products.
Key Responsibilities
- Conduct Audits: Perform audits of medical device manufacturers' QMS to ensure compliance with relevant standards and regulations (e.g., ISO 13485, MDR).
- Evaluate Technical Documentation: Review technical files and risk management processes related to non-active medical devices, with a focus on cardiology implants, ophthalmic devices, and animal tissue products.
- Assess Sterilization Processes: Evaluate the effectiveness and validation of sterilization processes, including steam, ethylene oxide (EtO), and other sterilization methods.
- Prepare Reports: Document findings, identify non-conformities, and prepare detailed audit reports.
- Client Interaction: Communicate effectively with clients, providing guidance and support on regulatory requirements and best practices.
- Continuous Improvement: Participate in internal training and contribute to the continuous improvement of auditing processes and methodologies.
Qualifications
- Educational Background: Bachelor's degree in Biomedical Engineering, Life Sciences, or a related field. Advanced degrees are a plus.
- Experience: Minimum of 4 years of experience in Quality Management Systems auditing, with specific expertise in sterilization and non-active medical devices.
- Certifications: Certified Lead Auditor (e.g., ISO 13485) preferred.
