Quality Engineer — CAPA & Audit Lead (Medical Devices)

Siemens Healthineers; Cary (NC); On-site; USD 89,000 - 123,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Retirement Plan

Life Insurance

Disability Insurance

Paid Parking

Paid Time Off

Paid Sick Time

Job summary

Siemens Healthineers is seeking a Quality Engineer to strengthen the CS Quality Management System and drive CAPA and document management improvements. The role centers on audits, cross-functional collaboration, and process optimization for medical devices.

You will lead CAPA activities, coach teams, and design training materials while ensuring regulatory compliance and continuous improvement across global operations.

Qualifications

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

Responsibilities

• Act as key audit lead; conduct internal and supplier audits with stakeholders.
• Own and oversee the CAPA process; lead CAPA meetings across functions.
• Coach CAPA Owners and Quality Managers; support CAPA Steering Board.
• Develop and refine process training materials for assigned areas.
• Manage process changes; balance timelines with user needs and impact.

Skills

Auditing

CAPA Management

Document Control

ISO 13485

FDA QMSR

Quality Systems

Cross-functional

Communication

Education

Quality/Engineering degree

Job description

Siemens Healthineers is seeking a Quality Engineer to strengthen the CS Quality Management System and drive CAPA and document management improvements. The role centers on audits, cross-functional collaboration, and process optimization for medical devices.

You will lead CAPA activities, coach teams, and design training materials while ensuring regulatory compliance and continuous improvement across global operations.