About This Role
This Quality Engineer role supports the effective operation of the Quality Management System (QMS) by managing controlled documentation, training processes, and Corrective and Preventive Actions (CAPAs). The position plays a key part in ensuring compliance with regulatory requirements, maintaining inspection readiness, and driving quality system effectiveness across the organization.
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
Requirements
- 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
- 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 consistently delivering high-quality results
- Strong communication and collaboration skills to work effectively across functions
About the Company
Siemens Healthineers is a leader in medical technology with more than 72,000 dedicated Healthineers in over 70 countries. The company constantly pushes boundaries to create better outcomes and experiences for patients, offering a portfolio crucial for clinical decision-making and treatment pathways.
