Quality Engineer
About The Position
Corning is seeking a Quality Engineer II to support manufacturing operations and project teams across assigned product lines. Reporting to the Quality Engineering Supervisor, this role provides quality guidance, product disposition decisions, and statistical problem-solving expertise for new product introduction, process improvements, continuous improvement initiatives, and validation activities. The position involves up to 15% travel, with the possibility of additional travel during the first six months. The role supports material review and non-conforming product investigations, customer complaint resolution, corrective and preventive actions, inspection and metrology improvements, quality planning, technical documentation, and compliance with applicable quality system and regulatory requirements. It also monitors environmental and water programs, including data trending, excursion identification, and corrective action oversight.
Requirements
- Bachelor's degree in engineering, statistics, or a related technical discipline.
- At least 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 ISO 13485, ISO 15378, FDA 21 CFR Part 820, and GDP/cGMP requirements.
- Proficiency in Minitab, Microsoft Project, and Microsoft Office applications.
- Demonstrated technical writing skills, including experience creating process documentation and quality plans.
- Ability to make product disposition decisions and evaluate CAPA effectiveness.
Nice To Haves
- Six Sigma certification (Green Belt or Black Belt).
- ASQ Certified Quality Engineer (CQE).
- Experience in medical device or pharmaceutical manufacturing.
- Familiarity with lean and continuous improvement methodologies.
Responsibilities
- Support Material Review Board activities, including blocked stock reviews, non-conforming product investigations, and customer complaint resolution.
- Facilitate Failure Investigation Reports, Situation Analysis, and Health Hazard Evaluation, documenting corrective actions clearly.
- Apply Six Sigma, FMEA, DOE, 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 for 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 ISO 13485, ISO 15378, FDA 21 CFR Part 820, and current Good Manufacturing Practices.
- 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, from collection through results trending.
- Make product disposition decisions and evaluate CAPA effectiveness.
Benefits
- Company-wide bonuses and long-term incentives.
- 100% company-paid pension benefit with fixed contributions.
- Matching contributions to the 401(k) savings plan.
- Medical, dental, and vision benefits.
- Paid parental leave and family building support.
- Fitness benefits.
- Company-paid life insurance and disability benefits.
- Disease management programs.
- Paid time off.
- Employee Assistance Program (EAP).
- Recognition program.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
