Lead Auditor

2 weeks ago


Delhi, Delhi, India Sofomation Full time

Lead Auditor Medical Device Position

Certification Body

Job Description:

  • 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.

Responsibilities:

  • Audit planning and execution in accordance with our procedures.
  • Maintaining effective relationships with clients and stakeholders.
  • Providing expert guidance on regulatory compliance and industry best practices.
  • Evaluating and reporting on audit findings and implementing corrective actions.
  • Staying up-to-date with relevant regulations and standards to ensure high-quality audit services.

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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