Quality Systems Engineer: Documentation, Training & CAPAs

Varian Medical Systems, Inc.

Schweiz

On-site

CHF 95,000 - 130,000

Full time

6 days ago
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Job summary

Varian Medical Systems, Inc. is seeking a Quality Engineer to support the Quality Management System through controlled documentation, training processes, and CAPAs.

The role ensures regulatory compliance, maintains inspection readiness, and enhances quality system effectiveness across the organization. The ideal candidate has a degree in a related field and experience in regulated environments such as healthcare or medical devices, with strong attention to detail and cross-functional

Qualifications

  • 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 in a regulated healthcare/medical devices environment.
  • Strong process- and compliance-oriented mindset with attention to detail and accuracy.
  • Excellent coordination, organization, and follow-up skills.
  • Ability to manage multiple priorities while delivering high-quality results.
  • Strong communication and collaboration skills across functions.

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 align training with regulatory and procedural expectations.
  • Promote awareness of quality system requirements and compliance obligations.
  • Support CAPA management including action tracking, follow-up, and due date monitoring.
  • Assist with quality investigations through collection of documentation and evidence.
  • Prepare quality metrics and reports related to investigations, CAPAs, and overall quality system performance.

Skills

Quality management
Document control
Training management
CAPA management
Regulatory compliance
Cross-functional collaboration
Attention to detail
Audit readiness
Regulatory standards ISO 13485
MDR / MDSAP knowledge

Education

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

Job description

Varian Medical Systems, Inc. is seeking a Quality Engineer to support the Quality Management System through controlled documentation, training processes, and CAPAs.

The role ensures regulatory compliance, maintains inspection readiness, and enhances quality system effectiveness across the organization. The ideal candidate has a degree in a related field and experience in regulated environments such as healthcare or medical devices, with strong attention to detail and cross-functional

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