Medical Device QMS Audit Manager - Remote

Overview

We are seeking a knowledgeable and driven Medical Device QMS Audit Manager to lead and oversee the training, qualification, and compliance processes for QMS Auditors involved in our medical device conformity assessments.

In Short

• Lead the development and delivery of training for QMS Auditors.
• Establish competence criteria and monitor qualification status.
• Provide expert technical guidance for conformity assessments.
• Support operational and strategic initiatives for SGS medical device services.
• Work with the Medical Devices Management Team to align processes with regulatory changes.
• Design and manage global training programs for auditors.
• Approve audits for auditor qualification and requalification.
• Contribute to recruitment and onboarding of new personnel.
• Develop QMS documentation aligned with relevant regulations.
• Ensure compliance and operational efficiency across teams.

Requirements

• Bachelor’s degree in medicine, pharmacy, engineering, or related field.
• 10+ years in the medical device industry, including 5 years in R&D or manufacturing.
• 4 years working within a Notified Body.
• 2 years of leadership experience.
• Qualified Lead Auditor under MDR and/or IVDR.
• Strong background in QMS auditing and technical file assessment.

Benefits

• Work with a global leader in inspection and certification.
• Collaborative and inclusive work environment.
• Competitive salary and benefits package.
• Opportunities for professional growth and development.