Quality Engineer, Life Sciences & Regulatory Support

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

Job summary

Corning Incorporated in Durham, NC is seeking a Quality Engineer to support quality and regulatory inquiries for the CMO projects and to act as a liaison with internal teams. You will investigate customer complaints, lead CAPAs, issue SCARs, manage change controls, and participate in customer audits to ensure compliance with ISO 9001 and ISO 13485.

This role emphasizes cross-functional collaboration, data analysis, and continuous improvement to deliver high-quality products and maintain

Qualifications

• Bachelor's degree in engineering, life sciences, or related field.
• 2-4 years experience in life sciences or manufacturing.
• Customer-facing interactions to address concerns.
• Knowledge of quality/regulatory practices (ISO 9001/13485).
• Experience with CAPA, change control, deviation investigations.
• Strong organization and communication skills.
• Ability to work cross-functionally with suppliers or labs.
• Proficient in data analysis and reporting.

Responsibilities

• Investigate issues and implement corrective actions for customer complaints.
• Communicate with customers about complaints and inquiries; escalate as needed.
• Prioritize inquiries to appropriate departments per QRS guidelines.
• Coordinate with contract manufacturers to resolve product concerns.
• Collaborate with Quality, Regulatory, Sales, and other teams to satisfy customers.
• Assist in customer audits and provide required documentation.
• Issue SCARs and manage CAPAs; track effectiveness.
• Create change controls to maintain QMS compliance.
• Support sterilization assurance for CMO products.
• Help improve QMS compliance, supply flexibility, and efficiency.
• Escalate issues per risk considerations.

Skills

Customer facing

Quality/regulatory

Cross-functional

Data analysis

Education

Bachelors in Engineering, life sciences, or related field

Tools

QMS

Job description

Corning Incorporated in Durham, NC is seeking a Quality Engineer to support quality and regulatory inquiries for the CMO projects and to act as a liaison with internal teams. You will investigate customer complaints, lead CAPAs, issue SCARs, manage change controls, and participate in customer audits to ensure compliance with ISO 9001 and ISO 13485.

This role emphasizes cross-functional collaboration, data analysis, and continuous improvement to deliver high-quality products and maintain