Quality Engineer: CAPA & Audit Leader in Medical Devices

Siemens Healthineers in; 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/public transport

Paid time off

Paid sick time

Job summary

Siemens Healthineers is seeking a Quality Engineer in Cary, NC to enhance the CSQuality Management System by strengthening CAPA and Document Management controls. You will participate in audits, lead CAPA efforts, manage process changes, and develop training materials for processes.

This role requires a regulated medical device background and up to travel as needed. Ideal candidates hold a quality/auditing background with ISO 13485/FDA knowledge and strong communication skills to drive continuous

Qualifications

• Bachelor's or Master's degree in Quality, Engineering, Natural Science or a related discipline preferred.
• 3+ years in Quality Management Systems; 5–7 years preferred in regulated medical device environment.
• Auditor Certification is REQUIRED; Lead Auditor certification preferred.

Responsibilities

• Audit participation and partner with cross-functional teams to strengthen quality processes.
• Lead internal and supplier audits with stakeholders to support audit activities.
• Own and oversee CAPA process; lead CAPA meetings and coach CAPA owners and Quality Managers.

Skills

Auditor Certification

Lead Auditor

Communication skills

Decision making

Travel readiness

Education

Bachelor's or Master's in Quality/Engineering/Natural Science

Job description

Siemens Healthineers is seeking a Quality Engineer in Cary, NC to enhance the CSQuality Management System by strengthening CAPA and Document Management controls. You will participate in audits, lead CAPA efforts, manage process changes, and develop training materials for processes.

This role requires a regulated medical device background and up to travel as needed. Ideal candidates hold a quality/auditing background with ISO 13485/FDA knowledge and strong communication skills to drive continuous