Quality Engineer: CAPA & QMS Lead (Medical Devices)

Regulatory Jobs; Cary (NC); Vor Ort; USD 89.000 - 123.000; Vollzeit

Benefits dieser Stelle

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

Zusammenfassung

Siemens Healthineers is seeking a Quality Engineer to drive CAPA effectiveness and document management controls within the CS Quality Management System. You will lead CAPA meetings, coach CAPA Owners, and support audits across internal and supplier networks.

The role requires a BS/MS in quality or engineering, 3+ years in a regulated medical device setting, and Lead Auditor certification. Travel may be required; base pay ranges are provided by the employer.

Qualifikationen

• Bachelor’s or Master’s degree in Quality, Engineering, Natural Science or related discipline preferred.
• Minimum 3 years of experience in Quality Management Systems in a regulated medical device environment.
• Auditor Certification REQUIRED; Lead Auditor certification preferred.
• Expert knowledge of ISO 13485 and FDA QMS regulations for medical devices.

Aufgaben

• Actively participate in audits and partner with cross functional teams to strengthen quality processes.
• Lead internal and supplier audits and support audit activities.
• Own and oversee the CAPA management process and lead CAPA meetings.
• Manage process changes with attention to timelines and user impact.
• Design and continuously improve training materials for assigned processes.

Kenntnisse

Auditing

Communication skills

Cross-functional collaboration

Presentation skills

Travel

Ausbildung

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

Jobbeschreibung

Siemens Healthineers is seeking a Quality Engineer to drive CAPA effectiveness and document management controls within the CS Quality Management System. You will lead CAPA meetings, coach CAPA Owners, and support audits across internal and supplier networks.

The role requires a BS/MS in quality or engineering, 3+ years in a regulated medical device setting, and Lead Auditor certification. Travel may be required; base pay ranges are provided by the employer.