Quality Systems Engineer – Pilot-Line Innovation

Corning, Inc.; City of Corning (NY); On-site; USD 92,000 - 126,000; Full time

Benefits offered by this job

Company bonuses

Pension plan

Health benefits

Paid time off

Employee recognition program

Job summary

Corning Incorporated is hiring a Quality Systems Engineer to build and improve a scalable QMS for pilot-line operations. You will own document control, CAPA, audit readiness, and risk-based quality practices across cross-functional teams.

You will partner with Engineering, Operations, and Manufacturing to integrate FMEA, control plans, and process mapping, ensuring compliance with ISO, GMP, and FDA standards as the pilot line scales.

Qualifications

• Bachelor’s degree in Engineering, Quality, Manufacturing, or a related technical discipline.
• Minimum of 3 years of experience in quality systems, quality assurance, or quality engineering within a manufacturing, pilot-line, or regulated environment.
• Hands-on experience developing, implementing, or managing QMS processes, including document control, change control, CAPA, complaint handling, and training record management.
• Experience applying risk-based quality methodologies, such as risk assessments, FMEA, and control plans.
• Working knowledge of applicable quality standards and regulatory frameworks, such as ISO 9001, ISO 13485, GMP, or FDA requirements.
• Experience supporting audits and maintaining ongoing inspection readiness.

Responsibilities

• Develop, implement, and manage core QMS processes for new pilot-line and manufacturing operations, including document control, change control, CAPA, complaint handling, and training record management.
• Lead root-cause analyses and CAPA investigations, leveraging data and trend analysis to implement systemic preventive actions and reduce process risk.
• Partner with Engineering, Operations, and Manufacturing to integrate risk-based quality tools into day-to-day pilot-line activities.
• Maintain audit readiness and support internal, customer, and regulatory audits, including preparation, facilitation, resolution of findings, and timely follow-up.
• Monitor QMS performance through metrics and leading indicators, identifying opportunities to drive continuous improvement and ensure scalability as the pilot line expands.

Skills

Quality systems

CAPA

FMEA

Audit readiness

Risk-based quality

GMP/ISO knowledge

Documentation control

Education

Bachelor’s degree in Engineering/Quality/Manufacturing

Tools

eQMS / document management

Job description

Corning Incorporated is hiring a Quality Systems Engineer to build and improve a scalable QMS for pilot-line operations. You will own document control, CAPA, audit readiness, and risk-based quality practices across cross-functional teams.

You will partner with Engineering, Operations, and Manufacturing to integrate FMEA, control plans, and process mapping, ensuring compliance with ISO, GMP, and FDA standards as the pilot line scales.