Quality Systems Engineer – Document Control & CAPA

439y Varian Medical Systems Imaging Laboratory GmbH; Schweiz; On-site; CHF 90,000 - 120,000; Full time

Job summary

Siemens Healthineers is seeking a highly organized Quality Engineer to support the QMS through management of controlled documents, training processes, and CAPAs. The role ensures regulatory compliance, inspection readiness, and quality system effectiveness across the organization.

Responsibilities include document control, training coordination, CAPA support, and quality investigations, with collaboration across functions to align training with regulatory expectations.

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 regulatory standards such as ISO 13485, MDR, and MDSAP.
• Familiarity with document control processes, records management, and training administration.
• Experience working in a regulated environment, preferably within healthcare, medical devices, or a similar industry.

Responsibilities

• Manage and maintain controlled quality documents and records in accordance with internal procedures and regulatory requirements.
• Coordinate document creation, review, approval, revision, and archival activities within the electronic document management system.
• Monitor document lifecycle activities and ensure timely updates of controlled documents.
• Support users with document management processes and system-related inquiries.
• Ensure quality records are complete, accurate, traceable, and audit-ready.
• Coordinate quality training programs and monitor training compliance across the organization.
• Support the development and maintenance of training curricula and learning plans.
• Partner with process owners to ensure training requirements align with regulatory and procedural expectations.
• Promote awareness of quality system requirements and compliance obligations.
• Support the management of CAPAs, including action tracking, follow-up activities, and due date monitoring.
• Assist with quality investigations through the collection of documentation, records, and supporting evidence.
• Prepare quality metrics and reports related to investigations, CAPAs, and overall quality system performance.

Skills

Quality management

Document control

CAPAs

Training management

Regulatory knowledge

Cross-functional collaboration

Education

Bachelor's degree

Job description

Siemens Healthineers is seeking a highly organized Quality Engineer to support the QMS through management of controlled documents, training processes, and CAPAs. The role ensures regulatory compliance, inspection readiness, and quality system effectiveness across the organization.

Responsibilities include document control, training coordination, CAPA support, and quality investigations, with collaboration across functions to align training with regulatory expectations.