Technical Manager, QMS - Remote

Overview

We are seeking a knowledgeable and driven Technical Manager, QMS 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 and qualification frameworks for technical staff.
• Establish and maintain competence criteria for QMS Auditors.
• Provide expert technical guidance across the conformity assessment process.
• Support operational and strategic initiatives for medical device services.
• Design and manage global training programs for QMS Auditors.
• Approve audits for auditor qualification and requalification.
• Contribute to recruitment and onboarding of new personnel.
• Develop QMS documentation aligned with regulatory guidance.
• Ensure compliance and operational efficiency across assessment teams.
• Provide technical support for SGS NB 1639 activities.

Requirements

• Bachelor’s degree in medicine, pharmacy, engineering, or related field.
• 10+ years in the medical device industry, with R&D or manufacturing experience.
• 4 years working within a Notified Body.
• 2 years of leadership experience.
• Qualification as a Lead Auditor under MDR and/or IVDR.
• Strong background in QMS auditing and applicable standards.
• Deep technical knowledge of medical device conformity assessment.
• Proven ability to develop and deliver training.
• Strong understanding of EU regulatory frameworks.
• Excellent communication and stakeholder engagement skills.

Benefits

• Opportunity to 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.