Quality Engineer, Regulatory & CAPA Lead

Corning Incorporated; North Carolina; On-site; USD 67,000 - 92,000; Full time

Benefits offered by this job

Bonuses and long-term incentives

401(k) and pension contributions

Health & wellness benefits

Job summary

Corning Incorporated seeks a Quality Engineer to support internal and external customers on quality and regulatory inquiries, acting as a liaison with other Corning functions and the CMO to sustain QMS compliance.

In this role you will investigate, implement corrective actions, manage CAPAs, participate in customer audits, and collaborate with cross-functional teams to ensure timely, compliant project deliverables and continuous improvement.

Qualifications

• Bachelors 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 ISO 9001 and ISO 13485 preferred.
• Understanding of quality systems, risk assessment, change control, deviation investigation, and CAPA.
• Proficiency with standard business software and data analysis tools.

Responsibilities

• Investigate, implement corrective actions and ensure proper disposition of items related to customer complaints.
• Provide responses and manage communications with customers for complaints and inquiries per policies.
• Prioritize key customers and urgent inquiries per QRS guidelines.
• Communicate with contract manufacturers to resolve product concerns.
• Collaborate with Quality, Regulatory, Sales, Operations, and Scientific Support to ensure timely deliverables.
• Participate in customer audits and provide documentation within audit scope.
• Issue SCARs, manage CAPAs and nonconformance reports for effective resolutions.
• Create change controls to maintain and support QMS compliance.
• Support sterilization assurance for CMO products as needed.
• Help implement changes to improve quality compliance and process efficiency.
• Escalate issues to ensure appropriate risk-based actions.

Skills

Quality systems

Regulatory practices

CAPA

Change control

Risk assessment

ISO 9001

ISO 13485

Document control

Customer facing

Data analysis tools

Education

Bachelors in Engineering, life sciences, or related field

Tools

Quality management software

Data analysis tools

Job description

Corning Incorporated seeks a Quality Engineer to support internal and external customers on quality and regulatory inquiries, acting as a liaison with other Corning functions and the CMO to sustain QMS compliance.

In this role you will investigate, implement corrective actions, manage CAPAs, participate in customer audits, and collaborate with cross-functional teams to ensure timely, compliant project deliverables and continuous improvement.