QA Engineer

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

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

We are seeking a highly organized and detail-oriented Quality Engineer to support the effective operation of the Quality Management System (QMS) through the management of controlled documentation, training processes, and Corrective and Preventive Actions (CAPAs). This role plays a key part in ensuring compliance with regulatory requirements, maintaining inspection readiness, and driving quality system effectiveness across the organization.

Key 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.

Required 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.
• 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.

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Who we are :

We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision‑making and treatment pathways.

How we work :

When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual's potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world's most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

To find out more about Healthineers' specific businesses, please visit our company page here .

As an equal opportunity employer, we welcome applications from individuals with disabilities.