Quality Engineer - Medical Devices, ISO 13485 & CQE Path

Corning Incorporated; Salt Lake City (UT); On-site; USD 67,000 - 92,000; Full time

Benefits offered by this job

Company-wide bonuses

Company-paid pension

401(k) matching

Comprehensive health benefits

Job summary

Corning Incorporated is seeking a Quality Engineer at our Salt Lake City, UT site to manage product quality, compliance, and continuous improvement within a regulated environment.

The role partners with Engineering, Operations, and Development teams to own nonconforming material processes, validations, sterilization programs, and ISO 13485-aligned quality systems.

Qualifications

• Bachelor’s degree in engineering or related technical field required.
• 1+ years quality experience in a regulated industry.
• Hands-on with sampling plans, AQL, 5 Why, DMAIC, fishbone, gauge R&R, MSA.
• Working knowledge of cGMP, GLP, or ISO standards.
• Proficient with MS Office suite.
• Demonstrated ability to perform root cause analysis and drive corrective actions.

Responsibilities

• Apply ISO 13485 QMS standards to support quality and compliance.
• Drive continuous improvement in manufacturing quality and cost reduction.
• Perform validations, equipment qualifications, test protocols; root cause investigations.
• Author/review SOPs and specifications; conduct internal/external audits.
• Collaborate with cross-functional teams to evaluate new product requirements and changes.

Skills

Quality tools

Root cause analysis

Statistical methods

MS Office

Regulated standards

AQL sampling

DMAIC

Fishbone analysis

Education

Bachelor's degree in Engineering or related technical discipline

Six Sigma Green Belt or higher

Certified Quality Engineer (CQE)

APICS certification

Tools

Excel

Word

PowerPoint

Visio

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: 77819

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 Engineer to support product quality, compliance, and continuous improvement at our Salt Lake City, UT manufacturing site. This role partners with Engineering, Operations, and Development teams to drive quality outcomes in a regulated environment, with core ownership of nonconforming material processes, validations, sterilization programs, and ISO 13485-aligned quality systems.

Key Responsibilities

• Apply ISO 13485 Quality Management System standards to support site quality and compliance; review test data and confirm results meet applicable specifications
• Drive continuous improvement in manufacturing quality and cost reduction; optimize sampling plans and manage the site sterilization program
• Perform validations, equipment qualifications, and test protocols; conduct root cause investigations for customer complaints and internal defects; implement corrective and preventive actions
• Author and review technical documentation, standard operating procedures, and specifications; perform internal and external audits
• Partner with cross-functional teams to evaluate new product requirements, develop site specifications, and ensure process changes meet quality, compliance, and productivity targets
  
  

Experiences/Education - Required

• Bachelor's degree in Engineering or a related technical discipline
• 1+ years of quality experience in a regulated industry environment
• Hands-on experience with quality and statistical tools including sampling plans, AQL, 5 Why, DMAIC, fishbone analysis, gauge R&R, and measurement systems analysis
• Working knowledge of regulated industry standards such as cGMP, GLP, or ISO
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Visio)
• Demonstrated ability to perform root cause analysis and drive corrective action implementation
  
  

Experiences/Education - Desired

• Experience in medical device manufacturing
• Familiarity with ISO 13485 standards, certification, or equivalent quality systems
• Six Sigma certification (Green Belt or higher)
• Certified Quality Engineer (CQE) certification
• APICS certification
  
  

This position does not support immigration sponsorship.

The range for this position is $67,237.00 - $92,451.00 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] .