Quality Systems Engineer, EIG

Corning•City of Corning, NY

31d•$91,649 - $126,018•Onsite

About The Position

Corning is seeking a Quality Systems Engineer to develop, implement, and continuously improve a scalable, risk-based Quality Management System (QMS) for pilot-line operations. This foundational role will establish the quality infrastructure—including document control, corrective and preventive action (CAPA), and audit readiness—needed to support a growing manufacturing environment. The successful candidate will help foster prevention-focused quality practices across cross-functional teams.

Requirements

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, Good Manufacturing Practice (GMP), or FDA requirements.
Experience supporting audits and maintaining ongoing inspection readiness.

Nice To Haves

Experience in a startup, pilot-line, low-volume manufacturing, or new manufacturing-site environment.
Experience establishing a QMS from the ground up, with an emphasis on scalability and preventive quality controls.
Experience supporting quality systems or quality engineering in precision optics, precision lens, camera, imaging, or other high-precision optical-component manufacturing environments.
Familiarity with electronic QMS (eQMS) platforms and/or document management systems.
Auditor training, internal audit experience, or both.
Background in Lean Six Sigma, continuous improvement, or process excellence.
Experience applying proactive quality engineering tools, such as Process Failure Mode and Effects Analysis (PFMEA), Statistical Process Control (SPC), control plans, process validation support, and mistake-proofing.
Experience supporting process scale-up, process transfer, or manufacturing-readiness activities.

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—including Failure Mode and Effects Analysis (FMEA), process mapping, and control plans—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.