Quality & CAPA Lead for Medical Devices

563d Siemens Medical Solutions USA, Inc.; California; Presencial; USD 89.000 - 123.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Life insurance

Long-term and short-term disability

Paid parking/public transportation

Paid time off

Paid sick and safe time

Descripción de la vacante

Siemens Healthineers is seeking a quality professional to lead internal and supplier audits, manage CAPA processes, and drive continuous improvement in medical device quality systems. This role requires cross-functional collaboration and strong communication across regions.

Able to coach CAPA owners, support audit activities, and develop training materials to improve process compliance and efficiency. Travel as needed.

Formación

• Bachelor’s or Master’s degree in Quality, Engineering or related discipline.
• Minimum 3 years of experience in Quality Management Systems in a regulated medical device environment; 5–7 years preferred.
• Auditor Certification REQUIRED; Lead Auditor certification preferred.
• Expert knowledge of ISO 13485 and FDA 21 CFR QMSR standards for medical devices.

Responsabilidades

• Lead audits and partner with cross-functional teams to strengthen quality processes and foster continuous improvement.
• Act as a key audit lead for internal and supplier audits and support audit activities.
• Own and oversee the end-to-end CAPA process and lead CAPA meetings.
• Coach CAPA Owners and Quality Managers; moderate CAPA Steering Board meetings during audits.
• Develop and continuously improve training materials for assigned processes.

Conocimientos

Auditing

CAPA management

Cross-functional collaboration

Audit planning

Intercultural communication

Educación

Bachelor’s/Master in Quality, Engineering or related

Herramientas

QMS

Descripción del empleo

Siemens Healthineers is seeking a quality professional to lead internal and supplier audits, manage CAPA processes, and drive continuous improvement in medical device quality systems. This role requires cross-functional collaboration and strong communication across regions.

Able to coach CAPA owners, support audit activities, and develop training materials to improve process compliance and efficiency. Travel as needed.