Career

Quality Management (m/f/d)

Location: On-site · Full-time

At Ermis MedTech, we develop precision solutions that protect medical instruments worldwide. To support our growing organization, we are looking for a motivated Quality Management who brings structure, responsibility, and attention to detail.

In this role, you will ensure compliance with regulatory requirements and actively contribute to maintaining and improving our quality management system.

Your Responsibilities

• Maintain and further develop the quality management system in accordance with ISO 13485 and MDR
• Plan, conduct, and follow up on internal and external audits
• Monitor and manage CAPA processes (Corrective and Preventive Actions)
• Create, review, and maintain technical documentation
• Handle complaints and support customer complaint management
• Qualify and evaluate suppliers from a quality perspective
• Ensure compliance with regulatory requirements (e.g. MDR, REACH, RoHS)
• Train and support employees on quality-related topics
• Communicate with authorities, notified bodies, and internal departments

Your Profile

• Completed degree or vocational training in Medical Technology or Quality Management
• ISO 13485 Lead Auditor / Internal Auditor certification
• Documented training in EU MDR (2017/745)
• Several years of experience in Quality Management and/or Regulatory Affairs within the medical device industry
• Very good knowledge of relevant standards and regulations (e.g. ISO 13485, MDR)
• Very good German and good English language skills
• Structured, independent, and detail-oriented working style
• Team spirit as well as analytical and solution-oriented thinking
• Confident handling of MS Office