Medical Device QMS Audit Manager
Our organization is seeking a seasoned Medical Device QMS Audit Manager to lead the development and delivery of training frameworks for our technical staff. The ideal candidate will establish competence criteria, monitor qualification status, and provide expert guidance across the conformity assessment process.
* Design and manage global training programs for QMS Auditors
* Approve Level 1 audits and witness audits for auditor qualification and requalification
* Contribute to recruitment, onboarding, and approval of new personnel
* Develop and maintain QMS documentation aligned with regulatory guidelines
* Ensure competence, compliance, and operational efficiency across assessment teams
The successful candidate must have a Bachelor's degree in medicine, pharmacy, engineering, or a related scientific field. A minimum of 10 years of experience in the medical device industry, including at least 5 years in R&D or manufacturing roles, and minimum 4 years working within a regulatory body are required.
The role requires strong technical knowledge of non-clinical aspects of medical device conformity assessment, proven ability to develop effective training, and excellent stakeholder engagement, problem-solving, and communication skills.