Quality Engineer - CAPA & Audit Lead (Medical Devices)

Siemens Healthineers AG; Cary, Northern (NC, KY); Hybrid; 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

Parking/public transportation paid

Paid time off

Paid sick time

Job summary

Siemens Healthineers AG is seeking a qualified Quality Compliance professional to lead audits and CAPA processes within a global medical device environment. The role emphasizes collaboration across cross-functional teams, CAPA leadership, and ongoing process improvements.

Ideal candidates hold auditor certification, with 5–7 years in QMS and expert knowledge of ISO 13485 and FDA requirements. Travel as needed, with a comprehensive benefits package.

Qualifications

• Degree in Quality, Engineering, Natural Science or related discipline preferred.
• Minimum 3 years in Quality Management Systems; 5–7 years preferred in a regulated medical device environment.
• Auditor Certification is REQUIRED; Lead Auditor preferred.
• Expert knowledge of ISO 13485 and FDA 21 CFR QMSR for medical devices.

Responsibilities

• Participate in audits; partner with cross-functional teams to improve quality processes.
• Act as key audit lead; conduct internal and supplier audits with stakeholders.
• Lead CAPA management: own end-to-end CAPA process and oversee CAPA meetings.
• Coach CAPA Owners and Quality Managers; moderate CAPA Steering Board meetings.
• Manage process changes to meet timelines with attention to user needs and impact.
• Design and improve training materials for assigned processes.

Skills

Auditing

Quality management

Communication skills

Cross-functional collaboration

Education

Bachelor/Master in Quality or Engineering or Natural Sciences

Tools

Lead Auditor Certification

Job description

Siemens Healthineers AG is seeking a qualified Quality Compliance professional to lead audits and CAPA processes within a global medical device environment. The role emphasizes collaboration across cross-functional teams, CAPA leadership, and ongoing process improvements.

Ideal candidates hold auditor certification, with 5–7 years in QMS and expert knowledge of ISO 13485 and FDA requirements. Travel as needed, with a comprehensive benefits package.