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Senior Quality Engineer

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Date: Jan 10, 2022

Location: Vineland, NJ, US, 08360

Company: Corning

Requisition Number: 50383

 

Corning is one of the world's leading innovators in materials science, with a 166-year track record of life-changing inventions. Corning applies its unparalleled expertise in glass science, ceramics science, and optical physics, along with its deep manufacturing and engineering capabilities, to develop category-defining products that transform industries and enhance people's lives. Corning Valor™ Glass is an example of a life-changing innovation purpose-built to store and protect injectable medicines. Corning is also a global leader in pharmaceutical tubing, manufacturing a variety of clear and amber glass tubing that is converted by our customers into vials, cartridges, ampules and syringes.

 

Scope of Position

• Managing the ongoing compliance of the Quality Management Systems to ISO, industry, and customer requirements and drive continuous improvement in the existing systems and deploy new systems as needed. Serves as the plant ISO Management Representative.

• Provide Quality Engineering support for continuous improvement, change management, and cost reduction projects across the plant, including statistical analysis and reporting as needed, facilitating the use of Performance Excellence tools, and driving the creation of a product quality architecture.

 

Day to Day Responsibilities

• Manage and execute the plant Quality Management Systems (QMS), including ISO documentation, CAPA, internal and external audits, change management, etc. to ensure the plant processes comply to ISO, industry, and customer requirements.

• EtQ Administrator for the site. Manages existing EtQ modules and is business lead with IT on the deployment of new modules. Coordinates EtQ among all CPG locations.

• Oversees all internal, 3rd party, corporate, and customer quality audits of the plant. Facilitates corrective action teams to resolve audit deficiencies.

• Manage the internal audit program and serve as a resource for performing audits around the plant for compliance to ISO 9001, 14001, and 15378.

• Manage the pest control program for the site though use of external contractors

• Work with Environmental Leader to ensure successful integration of EMS and QMS systems

• Drive and/or leads efforts for continuous improvement in Quality, manufacturing, and cost reduction for the site.

• Provides training to employees as needed on Quality-related systems

• Use risk-based approach to develop and improve quality management systems and make product quality decisions

• Participate in multi-plant QMS improvements with CPG, CPT, and CLS locations

• Provide leadership on process improvements for batch release, validation plans, calibration and metrology, inspection plans, deviations, quality metrics and report

• Provide support for Customer questionnaires and surveys, certifications, quality information requests, and supplier corrective action reports

• Serves as plant’s ISO Management Representative

• Drives improvements in cGMP understanding and practices

• Provide support to operations to resolve product quality issues on the production floor in real time

• Work with process and product engineering teams regarding key product attributes to develop appropriate control strategies and feedback loops to make sure product attributes perform as expected.

• Facilitate efforts in understanding processes, capability, and product quality architecture

• Be an active participant in the creation of product quality architecture

• Be an active participate in the creation of a Performance Excellence organization within the CPG division

 

Required Education & Experience

• BS/MS Degree in Engineering or Science

• 5-10 years of experience in Manufacturing, Engineering and/or Quality

• Minimum 4+ years quality systems experiences (regulated industry preferred – ISO, cGMP, GLP, CRF, FDA, etc)

 

Required Skills

• Understanding of basic statistical and data analysis concepts and their application in manufacturing

• Demonstrated strong interpersonal skills and the ability to build relationships with customers, suppliers, and co-workers (other locations)

• Knowledge of ISO management system and quality assurance

• Strong working knowledge of Microsoft Office Suite

 

Desired Skills

• Strong process management skills, such as thorough application of documented procedures

• Experience with Performance Excellence, Six Sigma training/certifications

• Experience performing internal audits

• Experience with data collection and data analysis software and techniques, such as Excel, Minitab, SPC XL, PI, MS-Access.

• Environmental hazard awareness

• Previous experience with EtQ Quality Management System

 

Soft Skills

• Strong verbal and written communication skills

• Open and engaging - able to interface effectively with others

• Experience working with outside suppliers and contractors

• Self-started; ability to drive things to closure

• Strong organizational skills

 

Hours of work/work schedule/flextime

• Flex time; typical minimum schedule is Monday to Friday, 8am to 5pm

• Some projects may require additional hours; supporting a 24/7/365 facility

• The plant has weekend teams that rotate coverage (six or seven weekends per year, including one major holiday or one to two minor holidays)

• Occasional weekend support for developments

 

Travel Requirements

• < 5% (training and off-site meetings)

 

This position does not support immigration sponsorship.

 

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.

 

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.


Nearest Major Market: Philadelphia