Quality Systems Engineer - Documentation & CAPA

Siemens Healthineers AG; Dättwil; On-site; CHF 90,000 - 120,000; Full time

Job summary

Siemens Healthineers AG in Switzerland seeks a highly organized Quality Engineer to support the Quality Management System (QMS) by managing controlled documents, training processes, and CAPAs. The role emphasizes regulatory compliance, inspection readiness, and continuous improvement across the organization.

You will coordinate document creation, reviews, and archival within the electronic document management system, monitor training compliance, and assist investigations with evidence and

Qualifications

• Bachelor's degree in a related field.
• Experience in quality systems, document control, training management, CAPAs.
• Knowledge of ISO 13485, MDR, and MDSAP.

Responsibilities

• Manage and maintain controlled quality documents and records in line with internal procedures and regulatory requirements.
• Coordinate creation, review, approval, revision and archival of documents in the electronic document management system.
• Monitor document lifecycle and ensure timely updates; support users and training administration.
• Coordinate quality training programs and monitor training compliance.
• Support CAPAs, investigations, action tracking, and metrics reporting.

Skills

Document control

CAPA management

Regulatory compliance

Quality systems

Cross-functional collaboration

Education

Bachelor's degree in Quality Management, Engineering, Life Sciences, Business Administration, or related field

Tools

Quality Management Software (QMS)

Job description

Siemens Healthineers AG in Switzerland seeks a highly organized Quality Engineer to support the Quality Management System (QMS) by managing controlled documents, training processes, and CAPAs. The role emphasizes regulatory compliance, inspection readiness, and continuous improvement across the organization.

You will coordinate document creation, reviews, and archival within the electronic document management system, monitor training compliance, and assist investigations with evidence and