Hybrid Quality Engineer: Document Control & CAPA

Siemens Healthineers AG; United States; Hybrid; USD 34,000 - 69,000; Part time

Job summary

Siemens Healthineers AG is seeking a QA Engineer to support the Quality Management System through controlled documentation, training processes, and CAPAs. The role emphasizes regulatory compliance, document control, and audit readiness in a hybrid, part-time capacity in the United States.

The position requires a Bachelor's degree and experience in quality systems, with ISO 13485, MDR, and MDSAP familiarity. Strong attention to detail and collaboration across functions are essential.

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.

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

Attention to detail

Coordination

Collaboration

Regulatory knowledge

Education

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

Job description

Siemens Healthineers AG is seeking a QA Engineer to support the Quality Management System through controlled documentation, training processes, and CAPAs. The role emphasizes regulatory compliance, document control, and audit readiness in a hybrid, part-time capacity in the United States.

The position requires a Bachelor's degree and experience in quality systems, with ISO 13485, MDR, and MDSAP familiarity. Strong attention to detail and collaboration across functions are essential.