Quality Engineer – Regulatory & CAPA Lead

Corning, Inc.; Durham (NC); On-site; USD 67,000 - 92,000; Full time

Job summary

The Quality Engineer at Corning Incorporated in Durham, NC provides quality and regulatory support for customers and the CMO projects. You will lead investigations, CAPAs, change controls, and collaborate with Quality, Regulatory, Sales, and Manufacturing teams to ensure compliance and timely project deliverables.

Requirements include a Bachelor's in Engineering or life sciences, 2–4 years in life sciences/manufacturing, strong ISO 9001/13485 familiarity, and excellent communication.

Qualifications

• Bachelor's in Engineering, life sciences, or related field.
• 2-4 years related experience in life sciences or manufacturing.
• Customer facing interactions to address concerns and resolve issues.
• Knowledge of quality and regulatory practices.
• Ability to prioritize and escalate tasks as needed.
• Experience with medical device/regulatory environments.

Responsibilities

• Investigate issues and implement corrective actions.
• Respond to customers and manage inquiries per policy.
• Escalate urgent quality/regulatory issues.
• Coordinate with contract manufacturers and internal teams.
• Support audits and provide documentation.
• Issue SCARs and manage CAPAs.
• Create change controls for projects.

Skills

Customer facing

Quality systems

Regulatory knowledge

CAPA & deviations

Cross-functional teamwork

Data analysis tools

Time management

ISO 9001/13485 familiarity

Education

Bachelor's in Engineering or Life Sciences

Job description

The Quality Engineer at Corning Incorporated in Durham, NC provides quality and regulatory support for customers and the CMO projects. You will lead investigations, CAPAs, change controls, and collaborate with Quality, Regulatory, Sales, and Manufacturing teams to ensure compliance and timely project deliverables.

Requirements include a Bachelor's in Engineering or life sciences, 2–4 years in life sciences/manufacturing, strong ISO 9001/13485 familiarity, and excellent communication.