Quality Engineer II | Medical Devices & Regulatory

Corning Inc.; Durham (NC); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Company bonuses & long-term incentives

Company-paid pension with 401(k) match

Health, dental, vision benefits

Job summary

Corning is seeking a Quality Engineer II to support manufacturing operations and project teams across assigned product lines. You will provide quality guidance, product disposition decisions, and statistical problem-solving expertise in NPI, process improvements, and validation activities.

Up to 15% travel is possible. Responsibilities include MRB support, quality plans, CAPA investigations, and environmental monitoring oversight.

Qualifications

• Bachelor's degree in engineering, statistics, or 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.

Responsibilities

• Support MRB activities including blocked stock reviews, non-conforming product investigations, and customer complaint resolution; facilitate FIRs, Situation Analyses, and Health Hazard Evaluations with corrective actions.
• Apply quality engineering tools (Six Sigma, FMEA, DOE, MSA, validation protocol) to support projects and manufacturing; assist with CAPA investigations.
• Develop and revise quality plans covering incoming, in-process, and final inspection; implement inspection and metrology improvements; review and approve DHF and create process documentation.
• Ensure compliance with ISO 13485, ISO 15378, FDA 21 CFR Part 820, and cGMP; support internal audits for quality system compliance.
• Monitor environmental and water monitoring programs including data trending, excursion ID, and corrective action oversight.

Skills

Six Sigma

FMEA

DOE

MSA

CAPA

Regulatory knowledge

Technical writing

Data analysis

Education

Bachelor's degree in engineering or statistics

Tools

Minitab

Microsoft Project

Microsoft Office

Job description

Corning is seeking a Quality Engineer II to support manufacturing operations and project teams across assigned product lines. You will provide quality guidance, product disposition decisions, and statistical problem-solving expertise in NPI, process improvements, and validation activities.

Up to 15% travel is possible. Responsibilities include MRB support, quality plans, CAPA investigations, and environmental monitoring oversight.