Quality Engineer

Key Responsibilities

• 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 requirements 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 Required Education & Experience 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 requirements 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 Desired Education & Experience 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. 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 [email protected] .