Job Description

Requisition Number: 43643

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 Manager, this position leads and supervises the Quality Engineering and Quality Control group to provide 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, CI, Engineering, Procurement and Marketing) and is responsible for the quality of the product and process for all product lines.

Day to Day Responsibilities:

* Lead the Quality Engineering team to troubleshoot equipment and methods, assist in the review of technical documents and provide technical support, participate in project meetings and monitor projects, lead, assign, monitor and implement projects, review trends and implement corrective actions.
* Lead the Quality Control team (Quality Associates, Quality Technicians, Quality Tech Supervisor, and QC/ Quality Associates) providing leadership and guidance for quality issues that occur during in-process manufacturing. Work closely with department team as well as other functions to resolve manufacturing issues quickly while ensuring product quality is maintained.
* Provide product team leadership and support including, Material Review Board (MRB), customer complaint activities, statistical analysis, validation support, inspection plans, metrology, calibration system, quality metrics and report functions. Communicate customer feedback to Quality Systems group. Assist in the development and implementation of appropriate corrective action plans.
* Support Corning Incorporated with Customer Notification Letters from plant projects as needed.
* Provide Division Level QA help desk support and problem resolution to include Questionnaires, Certificates, Supplier Corrective Action Reports (SCARS), and Customer Surveys etc.
* Facilitate, review and approve 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).
* 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.
* 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.

Travel Requirements:

* Up to 50% for first 6 months, then up to 5% long term.

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:

* BS Degree in an engineering, statistical field or equivalent technical degree.

Required Years and Area of Experience:

* Minimum 2 years supervisory/leadership experience.
* Minimum 4 years of manufacturing quality engineering experience.
* Minimum 2 years experience in validation application.

Required Skills:

* Thorough knowledge of the regulatory industry requirements ISO 15378, ISO 11137, ISO 13485, ISO 10993, ISO 14971, ISO 14644, 21 CFR Part 210/211, Part 820, and cGMP/GLP and USP requirements.
* Capable of the integration and application of user aimed manufacturing process documentation while meeting business and regulatory requirements.
* Working knowledge of databases, including SAP, EtQ, Access, spreadsheet applications, Microsoft Project, Minitab and word processing, to perform necessary tasks for preparing required data analysis, reports, documents and general communication.
* Ability to work independently with strong time management and prioritization skills to handle multiple assignments and interact with product teams.
* Ability to influence individuals without authority and to motivate others within a project team.
* Ability to make decisions regarding product disposition and corrective and preventive action effectiveness. Comfortable in giving direction to accomplish assigned tasks.
* Must be action oriented, make informed decisions, be self-motivated, capable of influencing without authority.
* Must be an effective communicator (written and verbal), highly organized, motivated, detail oriented with excellent analytical thinking and problem-solving skills.
* Flexibility to assume ownership on projects and coordinate the efforts of others to complete project goals or participate on a team to support other project Leads; must also possess the ability to effectively manage conflict.
* 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.

Desired Experience / Qualifications / Skills:

* ASQ Certified Quality Engineer

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