Medical Device Auditor (Notified Body) Confidential Client – Please apply through link

Job Description

As a Medical Device Auditor, you will play a crucial role in ensuring compliance with quality standards and regulations within the medical device industry. You will assess and evaluate processes, systems, and documentation to verify adherence to relevant guidelines. Your responsibilities will include conducting audits, analyzing data, and providing necessary training to staff.

Key Responsibilities:

Plan and conduct audits in accordance with accreditation requirements and internal procedures.
Coordinate audit procedures with clients and stakeholders.
Conduct on-site audits, prepare detailed reports, and clarify certificate contents as needed.
Assess internal processes, quality management systems, and documentation.
Analyze data and identify areas for improvement.
Provide training to medical staff on coding rules, local policies, and compliance.
Collaborate with cross-functional teams to promote quality and regulatory compliance.
Stay up-to-date with industry standards and regulations.
Qualifications and Skills:

Bachelor’s degree in a relevant field (e.g., biomedical engineering, life sciences, quality management).
Experience in quality management, preferably within the medical device industry.
Knowledge of ISO 13485, ISO 14971, and other relevant standards.
Strong analytical skills and attention to detail.
Excellent communication and interpersonal abilities.
Certification as a lead auditor or internal auditor is highly desirable.
Work Environment:

On-site audits at medical device manufacturing facilities.
Some remote work may be possible, depending on company policy.