Audits & CAPA Lead for Medical Devices

Regulatory Jobs; Cary (NC); On-site; USD 89,000 - 123,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) plan

Life insurance

Disability insurance

Paid parking/public transport

Paid time off

Paid sick time

Job summary

Siemens Healthineers is seeking a Regulatory Quality professional to lead audits, manage CAPAs, and drive continuous improvement in a global medical device environment. The role requires strong ISO 13485 and FDA knowledge, with Lead Auditor certification preferred.

The position supports cross-functional teams, ensures timely CAPA execution, and develops training materials to elevate process quality and compliance across the organization.

Qualifications

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

Responsibilities

• Actively participate in audits and strengthen quality processes across functions.
• Lead internal and supplier audits and support audit activities with stakeholders.
• Own and oversee the CAPA process; run CAPA meetings and act as SME during audits.
• Manage process changes with timelines, considering user needs and impact.
• Design and improve training materials for assigned processes.

Skills

Auditor Certification

Lead Auditor

ISO 13485

FDA 21 CFR QMSR

Education

Bachelor's or Master's degree in Quality, Engineering, Natural Science or related discipline

Job description

Siemens Healthineers is seeking a Regulatory Quality professional to lead audits, manage CAPAs, and drive continuous improvement in a global medical device environment. The role requires strong ISO 13485 and FDA knowledge, with Lead Auditor certification preferred.

The position supports cross-functional teams, ensures timely CAPA execution, and develops training materials to elevate process quality and compliance across the organization.