Quality Systems & Compliance Engineer (Healthcare)

onehealthineers; Schweiz; On-site; CHF 90,000 - 130,000; Full time

Job summary

Siemens Healthineers is seeking a highly organized Quality Engineer to support the Quality Management System by managing controlled documentation, training processes, and CAPAs. This role ensures regulatory compliance and audit readiness across the organization.

You will coordinate document creation, reviews, revisions, training curricula, and CAPA tracking, partnering with process owners to meet ISO 13485, MDR, and MDSAP requirements.

Qualifications

• Degree in quality management, engineering, life sciences, business, or related field.
• Experience with quality systems, document control, CAPAs.
• Knowledge of ISO 13485, MDR, and MDSAP.
• Experience in regulated healthcare/medical devices environment.
• Detail- and process-oriented with strong organizational skills.

Responsibilities

• Manage and maintain controlled quality documents and records.
• Coordinate document creation, review, approval, revision, archival.
• Monitor document lifecycle and ensure timely updates.
• Support users with document management processes.
• Ensure quality records are complete, traceable and audit-ready.
• Coordinate quality training programs and monitor compliance.
• Support the development and maintenance of training curricula.
• Partner with process owners to align training with regulatory expectations.
• Promote awareness of quality system requirements and compliance.
• Support CAPAs including tracking, follow-up, and due date monitoring.
• Assist with quality investigations through documentation collection.
• Prepare quality metrics and reports related to investigations and CAPAs.

Skills

Strong process and compliance mindset

Attention to detail

Coordination and organization

Cross-functional collaboration

Effective communication

Education

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

Job description

Siemens Healthineers is seeking a highly organized Quality Engineer to support the Quality Management System by managing controlled documentation, training processes, and CAPAs. This role ensures regulatory compliance and audit readiness across the organization.

You will coordinate document creation, reviews, revisions, training curricula, and CAPA tracking, partnering with process owners to meet ISO 13485, MDR, and MDSAP requirements.