Senior Auditor Medical Devices
7 days ago
About Sofomation
Sofomation is a leading provider of audit services for the medical device industry. We are committed to helping our clients navigate the complexities of regulatory compliance and ensure the quality and safety of their products.
Job Description
The successful candidate will be responsible for conducting thorough audits, either desk-based or on-site at clients' facilities, adhering to established procedures and maintaining exceptional customer service standards.
Key Responsibilities
- Conduct thorough audits, either desk-based or on-site at clients' facilities, adhering to established procedures and maintaining exceptional customer service standards.
- Demonstrate in-depth knowledge of ISO 13485, MDD 93/42/EEC, Indian Medical Device Regulations, and their practical applications.
- Familiarity with Risk Management principles based on EN ISO 14971.
- Possess current registration as a Lead Auditor from the International Register of Certificated Auditors (IRCA) or equivalent certification from another recognized auditing body.
- Having a Qualified MDR Assessor designation from a reputable EU Notified Body is desirable.
Requirements
- Minimum 5 years of experience in medical device auditing or a related field.
- Proven track record of delivering high-quality audit services and fostering strong client relationships.
- In-depth knowledge of relevant regulations and standards, including ISO 13485, MDD, and MDR.
- Excellent communication and interpersonal skills.
- Ability to work independently and as part of a team.
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