Quality Systems Engineer - Pilot-Line Quality & CAPA Lead

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

Benefits offered by this job

Bonus program

401(k) plan

Health benefits

Paid time off

Job summary

Corning is seeking a Quality Systems Engineer to develop, implement, and continuously improve a scalable QMS for pilot-line operations. This foundational role builds the quality infrastructure—document control, CAPA, and audit readiness—to support a growing manufacturing environment.

The successful candidate will lead root-cause analyses, apply risk-based quality tools, and work with cross-functional teams to ensure compliance with ISO and FDA requirements, enabling scalable quality practices

Qualifications

• Bachelor’s degree in Engineering, Quality, Manufacturing, or related discipline.
• Minimum of 3 years in quality systems within manufacturing or regulated environment.
• Experience building, implementing, or managing QMS processes (document control, change control, CAPA, complaint handling, training records).
• Experience applying risk-based quality methodologies, such as risk assessments, FMEA, and control plans.
• Working knowledge of ISO 9001, ISO 13485, GMP, or FDA requirements.
• Experience supporting audits and maintaining 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, using data and trend analysis to implement preventive actions.
• Partner with Engineering, Operations, and Manufacturing to integrate risk-based quality tools (FMEA, process mapping, control plans) into day-to-day activities.
• Maintain audit readiness and support internal, customer, and regulatory audits, including preparation and follow-up.
• Monitor QMS performance through metrics and leading indicators to drive continuous improvement as the pilot line expands.

Skills

QMS development

CAPA investigations

FMEA

Audit readiness

Document control

Change control

Regulatory knowledge

GMP/FDA

Root-cause analysis

Data analysis

Education

Bachelor’s in Engineering

Related technical discipline

Tools

eQMS platforms

Job description

Corning is seeking a Quality Systems Engineer to develop, implement, and continuously improve a scalable QMS for pilot-line operations. This foundational role builds the quality infrastructure—document control, CAPA, and audit readiness—to support a growing manufacturing environment.

The successful candidate will lead root-cause analyses, apply risk-based quality tools, and work with cross-functional teams to ensure compliance with ISO and FDA requirements, enabling scalable quality practices