Quality Systems Engineer — Document Control & CAPA

Siemens Healthineers AG; Baden; 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, manage controlled documentation, training processes, and CAPAs, ensuring regulatory compliance and audit readiness across the organization.

You will coordinate document lifecycle, maintain training curricula, and collaborate with process owners to align quality practices with ISO 13485, MDR, and MDSAP requirements, delivering reliable patient-centered outcomes.

Qualifications

• Bachelor's degree in Quality Management, Engineering, Life Sciences, Business Administration, or a related field.
• Experience in quality systems, document control, training management, CAPAs, or a related quality function.
• Knowledge of ISO 13485, MDR, and MDSAP.
• Familiarity with document control processes, records management, and training administration.
• Experience working in a regulated healthcare/medical devices environment.
• Strong attention to detail and compliance mindset.

Responsibilities

• Manage and maintain controlled quality documents and records per procedures and regulatory requirements.
• Coordinate document creation, review, approval, revision, and archival in the electronic document management system.
• Monitor document lifecycle and ensure timely updates of controlled documents.
• Support users with document management processes and system inquiries.
• Ensure quality records are complete, traceable, and audit-ready.
• Coordinate quality training programs and monitor training compliance.
• Develop and maintain training curricula and learning plans.
• Partner with process owners to align training with regulatory expectations.
• Promote awareness of quality system requirements and compliance obligations.
• Support CAPA management, including tracking and follow-up.
• Assist with quality investigations and collection of records.
• Prepare quality metrics and reports related to investigations, CAPAs, and system performance.

Skills

Quality management

Documentation control

Training management

Regulatory compliance

Communication & collaboration

Education

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

Tools

Electronic document management systems

Job description

Siemens Healthineers AG in Switzerland seeks a highly organized Quality Engineer to support the Quality Management System, manage controlled documentation, training processes, and CAPAs, ensuring regulatory compliance and audit readiness across the organization.

You will coordinate document lifecycle, maintain training curricula, and collaborate with process owners to align quality practices with ISO 13485, MDR, and MDSAP requirements, delivering reliable patient-centered outcomes.