Senior Quality Manager — Lead QMS/eQMS for Class III Devices

AOP Health; Wien; On-site; EUR 45,000 - 55,000; Full time

Benefits offered by this job

Open corporate culture

Professional development

Flat hierarchies

Competitive salary package

Job summary

OrphaCare, a subsidiary of AOP Health, is seeking a Senior Quality Manager to join the QARA team. The role focuses on developing and maintaining a robust QMS for Class III implantable medical devices, aligning with ISO 13485 and MDR/FDA standards.

You will drive eQMS implementation, ensure validated processes, and collaborate with QA, RA and technical teams to harmonize quality across sites. This fixed-term role supports ongoing quality initiatives.

Qualifications

• Degree in scientific, engineering or quality-related discipline.
• 7-10 years of experience in medical device quality management.
• Practical knowledge of ISO 13485, EU MDR and FDA requirements.
• Hands-on experience with eQMS implementation and training.

Responsibilities

• Develop, maintain, and improve the QMS per ISO 13485 and MDR/FDA.
• Identify QMS gaps and drive procedures, records, and templates.
• Harmonize quality processes across sites.
• Collaborate with QA/RA/technical teams on design controls, risk, supplier management, production controls, validation, complaints, and PMS.
• Lead eQMS deployment and validation efforts.

Skills

Quality management

Cross-functional collaboration

eQMS implementation

Audits & CAPA

Education

Degree in scientific/engineering/quality

7-10 years in medical device quality management

Tools

eQMS

Job description

OrphaCare, a subsidiary of AOP Health, is seeking a Senior Quality Manager to join the QARA team. The role focuses on developing and maintaining a robust QMS for Class III implantable medical devices, aligning with ISO 13485 and MDR/FDA standards.

You will drive eQMS implementation, ensure validated processes, and collaborate with QA, RA and technical teams to harmonize quality across sites. This fixed-term role supports ongoing quality initiatives.