IVD Auditor - California, United States - EPM Scientific

Description

IVD Lead Auditor

Job type: Permanent

Location: Home Based (USA)

A renowned and well-established Notified Body that are committed to ensuring the safety and efficacy of medical devices are looking for a Senior IVD Notified Body Auditor and play a pivotal role in shaping the future of healthcare.

Responsibilities:

• Lead and conduct in-depth and comprehensive audits of IVD manufacturers to assess their compliance with applicable regulations, standards, and quality management systems.
• Evaluate technical documentation, including design dossiers and technical files, to ensure conformity with relevant directives and guidelines.
• Provide expert guidance and support to clients, fostering constructive relationships and helping them achieve and maintain compliance excellence.
• Keep abreast of the latest regulatory updates, industry trends, and best practices to ensure audits are conducted in alignment with the most current standards.
• Collaborate closely with our dynamic team to enhance audit processes and contribute to continuous improvement initiatives.

Requirements:

• Bachelor's degree in a relevant scientific or engineering discipline.
• A minimum of 5 years of experience in the IVD industry, with a strong focus on auditing and quality management systems.
• In-depth knowledge of relevant regulations, including IVDR (In Vitro Diagnostic Medical Devices Regulation), ISO 13485, and other applicable standards.
• Minimum 2 years' experience as an Auditor at a Notified Body
• Excellent communication and interpersonal skills to engage with stakeholders effectively.
• Please reach out to or call for more information.