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Quality Engineer

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Date: Apr 7, 2021

Location: Durham, NC, US, 27712

Company: Corning

Requisition Number: 44328

 

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:

Reporting directly to the Quality Engineering Supervisor, this position involves product team support for the manufacturing operations, provides quality guidance, product resolution decisions, and statistical problem-solving techniques to manufacturing operations and project teams for new product introduction, process improvements, continuous improvements, and validation activities. This position works closely with other functions within the organization (Manufacturing, R&D, Continuous Improvement, Quality, Engineering, Procurement, and Marketing) and is responsible for the quality of the product and process for the assigned product line(s).

Day to Day Responsibilities:  

  • Provide product team support including, Material Review Board (MRB), customer complaint activities, statistical analysis, validation support, inspection plans, metrology, quality metrics and report functions.  
  • Quality help desk and customer complaint point of contact and problem resolution including Questionnaires, Certificates, and Customer Surveys etc.  
  • Facilitate investigation of Failure Investigation Reports (FIR), Situation Analysis (SA) and Health Hazard Evaluation (HHE) with clear documentation of corrective actions.  
  • Lead discussions on blocked stock and open notifications in Material Review Board (MRB). 
  • Assist with the investigation of Corrective & Preventive Actions (CAPA), non-conforming product, and customer complaints, providing solutions where possible. Communicate customer feedback to Quality Systems group.  
  • Apply quality engineering practices and guidance to support project teams and manufacturing operations using Six Sigma tools, FMEA, CE Diagram, DOE, MSA, Validation Protocol development, review, approval and Control Plans.  
  • Support Continuous Improvement activities and key plant projects.  
  • Develop/Revise Quality Plans including: incoming, in-process and final inspection, and provide training to those affected by the plans. 
  • Implement proven inspection and metrology improvements and associated training.  
  • Review and approve Project Design History Files.  
  • Create technical process documents that fit the business needs and maintain compliance to the regulatory requirements of the FDA and ISO standards.  
  • Serve as a resource for performing internal audits to ensure quality system compliance.  
  • Able to react to change and perform other duties as assigned.

Travel Requirements:  

  • Up to 5%, possibly more during first 6 months

Hours of work/work schedule/flex-time: 

  • Exempt position working approximately 40 hours per week, Monday to Friday, with flexibility to support project assignments and off shifts.

Required Education:  

  • Bachelor’s Degree in Technical field

Required Years and Area of Experience: 

  • Minimum of 2 years of manufacturing quality engineering experience (preferably in a regulated industry such as medical device)

Required Skills:  

  • Ability to work independently with strong time management and prioritization skills to handle multiple assignments and interact with product teams.  
  • Ability to make decisions regarding product disposition and corrective and preventive action effectiveness. Comfortable in giving direction to accomplish assigned tasks.  
  • Knowledge of manufacturing processes and relevant statistical methods for quality assurance, i.e., capable of Six-Sigma skills, certification preferred.  
  • Good understanding of Continuous Improvement Methodologies, including lean, six sigma, statistical applications and validation.  
  • Proficiency in Minitab, Microsoft project, word processing, database, and spreadsheet applications.  
  • Demonstrated technical writing skills.  
  • Thorough knowledge of the regulatory industry requirements ISO13485, ISO 15378, Quality Management Systems, Regulation CFR 21 part 820, GDP / cGMP

Desired Qualifications: 

  • Six Sigma certification  
  • ASQ Certified Quality Engineer 

 

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, or 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: Durham
Nearest Secondary Market: Raleigh