Quality Engineer

• ◆Support Material Review Board (MRB) activities including blocked stock reviews, non-conforming product investigations, and customer complaint resolution; facilitate Failure Investigation Reports (FIR), Situation Analysis, and Health Hazard Evaluation with clear documentation of corrective actions
• ◆Apply quality engineering tools — including Six Sigma, Failure Mode and Effects Analysis (FMEA), Design of Experiments (DOE), Measurement System Analysis (MSA), and validation protocol development — to support project teams and manufacturing operations; assist with Corrective and Preventive Action (CAPA) investigations
• ◆Develop and revise quality plans covering incoming, in-process, and final inspection; implement inspection and metrology improvements; review and approve Project Design History Files and create technical process documentation
• ◆Ensure compliance with regulatory

including ISO 13485, ISO 15378, FDA 21 CFR Part 820, and current Good Manufacturing Practices (cGMP); serve as a resource for internal audits supporting quality system compliance

• ✓Monitor environmental and water monitoring programs including data trending, excursion identification, and corrective action oversight; manage from collection through results trending

• ✓Bachelor's degree in engineering, statistics, or a related technical discipline
• ✓3+ years of high volume manufacturing quality engineering experience, preferably in a regulated industry such as medical devices
• ✓Knowledge of quality engineering tools including Six Sigma, FMEA, DOE, MSA, and validation methodology
• ✓Thorough knowledge of regulatory

including ISO 13485, ISO 15378, FDA 21 CFR Part 820, and GDP/cGMP

• ✓Proficiency in Minitab, Microsoft Project, and Microsoft Office applications
• ✓Demonstrated technical writing skills with experience creating process documentation and quality plans
• ✓Ability to make product disposition decisions and evaluate CAPA effectiveness

• ✓Six Sigma certification (Green Belt or Black Belt)
• ✓ASQ (American Society for Quality) Certified Quality Engineer (CQE)
• ✓Experience in medical device or pharmaceutical manufacturing
• ✓Familiarity with lean and continuous improvement methodologies

This position does not support immigration sponsorship.

The range for this position is $80,011.00 - $110,016.00 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.

• ✓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 an