Senior Quality Manager: Implantable Devices & eQMS Lead

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

Benefits offered by this job

Bonus

Excellent career opportunities

Job summary

AOP Health Group in Vienna seeks a Senior Quality Manager (Orpha Care) to lead the development and maintenance of the QMS for Class III implantable devices and advance the eQMS rollout.

You will drive QMS alignment across sites, collaborate with QA, RA and technical teams, and ensure compliance with ISO 13485, EU MDR and FDA QMSR. This fixed-term role runs until 31 December 2028 with a competitive salary and bonus.

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, and quality management processes.
• Experience in developing procedures, implementing QMS continual improvements, and managing quality documentation.
• Hands-on experience with eQMS implementation, administration, validation, and training.
• Experience with audits, CAPA, change control, and management review processes.

Responsibilities

• Develop, maintain, and continuously improve the Quality Management System in accordance with ISO 13485:2016 and applicable EU MDR and FDA QMSR requirements.
• Identify QMS gaps and drive the development, revision, and implementation of procedures, work instructions, templates, and records.
• Harmonize quality processes and documentation across company sites.
• Collaborate closely with QA, RA, and technical teams to establish and maintain compliant quality processes covering design controls, risk management, supplier management, production controls, validation, complaints, and post-market surveillance.
• Support and lead key activities related to the implementation and deployment of the electronic Quality Management System (eQMS).
• Define user requirements, workflows, document structures, metadata, access permissions, and reporting requirements for the eQMS.
• Coordinate validation activities, user training, and go-live support to ensure the eQMS remains in a validated state.

Skills

Quality management

Cross-functional collaboration

Regulatory knowledge

Audits

CAPA

Documentation

Education

Degree in scientific, engineering or quality-related discipline

Tools

eQMS

Job description

AOP Health Group in Vienna seeks a Senior Quality Manager (Orpha Care) to lead the development and maintenance of the QMS for Class III implantable devices and advance the eQMS rollout.

You will drive QMS alignment across sites, collaborate with QA, RA and technical teams, and ensure compliance with ISO 13485, EU MDR and FDA QMSR. This fixed-term role runs until 31 December 2028 with a competitive salary and bonus.