Medical Device Auditor

Medical Device Auditor Overview

Join Scarlet as a Medical Device Auditor and play a vital role in ensuring the safety, quality, and compliance of medical devices. This position involves conducting detailed audits across various stages of medical device manufacturing and documentation review to verify adherence to regulatory standards and internal quality protocols.

Key Responsibilities

• Perform thorough audits of medical devices, examining manufacturing processes, technical documentation, and quality management systems.
• Identify non-conformance issues and provide recommendations for corrective actions to uphold safety and regulatory compliance.
• Collaborate with teams across engineering, manufacturing, and regulatory departments to facilitate audit procedures and improve quality standards.
• Document audit findings comprehensively in reports, highlighting areas of compliance and concern for management review.
• Keep abreast of the latest regulations, standards, and industry best practices related to medical device quality assurance and compliance.

Candidate Requirements

• Experience in auditing within the medical device or healthcare industry is essential.
• Strong knowledge of relevant regulations such as ISO 13485, MDR, and FDA standards.
• Excellent attention to detail and analytical skills for reviewing technical documentation and manufacturing processes.
• Effective communication skills to clearly articulate audit findings and collaborate with multidisciplinary teams.
• Ability to work independently, manage multiple audits, and meet deadlines efficiently.
• Qualifications or certifications in quality management or medical device regulation are advantageous.

Benefits

• Competitive salary aligned with experience and expertise.
• Opportunities for ongoing professional development and training.
• A collaborative and supportive work environment.
• Potential for career growth within the company.
• Flexible working arrangements may be available depending on the role.

This role is open to candidates requiring visa sponsorship, and we are pleased to offer support for the right applicant to obtain the necessary work authorization.

Degree Requirement: Bachelor’s

Visa Sponsorship May be