Quality Systems Engineer, EIG

Corning Incorporated; 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

The company built on breakthroughs. Join us.

Corning is one of the world’s leading innovators in glass, ceramic, and materials science. From the depths of the ocean to the farthest reaches of space, our technologies push the boundaries of what’s possible.

Requisition Number: 78016

The company built on breakthroughs. Join us.

Corning is one of the world’s leading innovators in glass, ceramic, and materials science. From the depths of the ocean to the farthest reaches of space, our technologies push the boundaries of what’s possible.

How do we do this? With our people. They break through limitations and expectations– not once in a career, but every day. They help move our company, and the world, forward.

At Corning, there are endless possibilities for making an impact. You can help connect the unconnected, drive the future of automobiles, transform at-home entertainment, and ensure the delivery of lifesaving medicines. And so much more.

Come break through with us.

Corning’s Businesses Are Ever-evolving To Best Serve Our Customers, Industries, And Consumers. Today, We Accelerate And Transform Life Sciences, Mobile Consumer Electronics, Optical Communications, Display, Automotive, And Solar Markets. We Are Changing The World With

• Trusted products that accelerate drug discovery, development, and delivery to save lives
• Damage-resistant cover glass to enhance the devices that keep us connected
• Optical fiber, wireless technologies, and connectivity solutions to carry information and ideas at the speed of light
• Precision glass for advanced displays to deliver richer experiences
• Auto glass and ceramics to drive cleaner, safer, and smarter transportation
• Solar polysilicon, wafers, and innovative photovoltaic modules, enabling low-cost solar energy solutions

Role Purpose

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.

Key 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.

Experiences/Education - Required

• 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.

Experiences/Education - Desired

• 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.

This position does not support immigration sponsorship.

The range for this position is $91,649.00 - $126,018.00 assuming full time status. Starting pay for the successful applicant is dependent on a variety of job-related factors, including but not limited to geographic location, market demands, experience, training, and education.

A job that shapes a life.

Corning offers you the total package.

Your well-being is our priority. Our compensation and benefits package supports your health and wellness, financial aspirations, and career from day one.

• Company-wide bonuses and long-term incentives align with key business results and ensure you are rewarded when the company performs well. When Corning wins, we all win.
• As part of our commitment to your financial well-being, we provide a 100% company-paid pension benefit with fixed contributions that grow throughout your career. Combined with matching contributions to your 401(k) savings plan, Corning’s total contributions to your retirement accounts can reach between 7% and 12% of your pay, depending on your age and years of service.
• Our health and well-being benefits include medical, dental, vision, paid parental leave, family building support, fitness, company-paid life insurance, disability, disease management programs, paid time off, and an Employee Assistance Program (EAP) to support you and your family.
• Getting paid for our work is important, but feeling appreciated and recognized for those contributions motivates us much more. That’s why Corning offers a recognition program to celebrate successes and reward colleagues who make exceptional contributions.

We prohibit discrimination on the basis of race, color, gender, age, religion, national origin, sexual orientation, gender identity or expression, disability, veteran status or any other legally protected status.

Corning is committed to providing equal employment opportunities and considers requests for reasonable accommodations in accordance with applicable laws. Individuals with disabilities or sincerely held religious beliefs may request reasonable accommodations to participate in the application or interview process, perform essential job functions, or access other benefits and privileges of employment. To submit a request for reasonable accommodation related to disability or religion, please contact us at [e-mail].