Quality Systems Engineer — Pilot-Line QA & QMS

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

Benefits offered by this job

Company-wide bonuses

Pension and 401(k) contributions

Health and well-being benefits

Paid time off

Job summary

Corning, Inc. is seeking a Quality Systems Engineer to design, implement, and scale a risk-based QMS for pilot-line manufacturing.

The role emphasizes document control, CAPA, audits, and cross-functional collaboration with Engineering and Operations. The successful candidate will have a BS in Engineering/Quality, 3+ years in quality systems within manufacturing, and hands-on experience with PFMEA, SPC, and control plans.

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 ISO 9001, ISO 13485, GMP, or FDA requirements.
• Experience supporting audits and maintaining ongoing inspection readiness.
• Experience in startup, pilot-line, low-volume manufacturing, or new manufacturing-site environment.
• Experience establishing a QMS from the ground up, with scalability and preventive quality controls.
• Experience supporting quality systems or quality engineering in precision optics or related high-precision manufacturing environments.
• Familiarity with electronic QMS (eQMS) platforms and/or document management systems.
• Auditor training or internal audit experience.
• Lean Six Sigma, continuous improvement, or process excellence background.
• Experience applying PFMEA, SPC, control plans, process validation, and mistake-proofing.
• Experience supporting process scale-up, process transfer, or manufacturing-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

QMS

CAPA

FMEA

Document control

Audit readiness

Root-cause analysis

Control plans

Process mapping

Risk-based quality

Regulatory knowledge

Education

Bachelor’s degree in Engineering, Quality, Manufacturing, or related technical discipline

Tools

eQMS platforms

Job description

Corning, Inc. is seeking a Quality Systems Engineer to design, implement, and scale a risk-based QMS for pilot-line manufacturing.

The role emphasizes document control, CAPA, audits, and cross-functional collaboration with Engineering and Operations. The successful candidate will have a BS in Engineering/Quality, 3+ years in quality systems within manufacturing, and hands-on experience with PFMEA, SPC, and control plans.