Quality Systems Engineer – CAPA & Training Lead

Siemens Medical Solutions USA, Inc.; Schweiz; On-site; CHF 90,000 - 130,000; Full time

Job summary

Siemens Healthineers is seeking a Quality Engineer to support the Quality Management System, ensuring compliant documentation, training processes, and CAPAs. You will help maintain inspection readiness and drive quality system effectiveness in a regulated healthcare environment.

This role emphasizes cross-functional collaboration, meticulous attention to detail, and the ability to manage multiple priorities while delivering high-quality results.

Qualifications

• Bachelor's degree in quality management, engineering, life sciences, business administration, or related field.
• Experience in quality systems, document control, training management, CAPAs, or related quality function.
• Knowledge of ISO 13485, MDR, and MDSAP.
• Familiarity with document control processes, records management, and training administration.
• Experience in a regulated healthcare/medical devices environment.
• Detail-oriented with strong compliance mindset.
• Excellent coordination and cross-functional collaboration skills.
• Ability to manage multiple priorities while delivering high-quality results.

Responsibilities

• Manage and maintain controlled quality documents and records.
• Coordinate document creation, review, approval, revision, and archival activities.
• Monitor document lifecycle and ensure timely updates of controlled documents.
• Support users with document management processes and system inquiries.
• Ensure quality records are complete, accurate, traceable, and audit-ready.
• Coordinate quality training programs and monitor training compliance.
• Support development and maintenance of 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 action tracking and due date monitoring.
• Assist with quality investigations through documentation collection.
• Prepare quality metrics and reports related to investigations and CAPAs.

Skills

Quality systems

Document control

Training management

CAPA management

Regulatory standards

Records management

Healthcare industry

Cross-functional collaboration

Education

Bachelor's degree in Quality Management or related field

Job description

Siemens Healthineers is seeking a Quality Engineer to support the Quality Management System, ensuring compliant documentation, training processes, and CAPAs. You will help maintain inspection readiness and drive quality system effectiveness in a regulated healthcare environment.

This role emphasizes cross-functional collaboration, meticulous attention to detail, and the ability to manage multiple priorities while delivering high-quality results.