Quality Engineering Supervisor

Company Name:
Company Overview:
Corning Life Sciences brings new and innovative laboratory tools to researchers. Our core technical competencies include polymer science, biochemistry and molecular biology, glass melting and forming, surface modification, and characterization science. As part of Corning Incorporated, we are a world leader in specialty glass and have a 150-year tradition of innovation.
We are committed to meeting customers unique and changing needs with original solutions for todays emerging life sciences technologies. Our dedication to quality, technology and innovation has enabled us to produce the worlds most comprehensive line of laboratory tools for life science research. Corning Life Sciences also offers custom capabilities such as special packaging, bar coding, and printed lot numbers, to meet specific customer requirements
To know more about Corning Life Sciences, visit us at:
Role Purpose:
Reporting directly to the Plant Quality Manager, this position leads and supervises the Quality Engineering group to provide team technical support for the manufacturing and business 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 (Quality, Commercial, Operations, Development, Engineering, Procurement, and Marketing) and is responsible for the quality of the product and process for all product lines.
Key Responsibilities:
Provide product team leadership and support including, MRB, customer complaint activities, statistical analysis, validation support, inspection plans, metrology, quality metrics and report functions. Communicate customer feedback to Quality Systems group. Assist in the development and implementation of appropriate corrective action plans.
Manages customer complaints process with regards to timelines, customer follow up, etc. to prevent escalation of issues. Reviews and trends customer complaint data recommending improvement opportunities for all areas of the facility.
Assist and/or lead other staff or departments, when necessary, to perform investigations and resolutions of customer complaints and other root cause investigations.
Manages the customer technical inquiry process to ensure appropriate and accurate responses regarding Mediatech products and processing ensuring confidential and proprietary information is safeguarded.
Participates in Performance Excellence activities to quickly and effectively support improvement initiatives.
Authors and/or performs technical reviews of various technical documentation, SOPs, and specifications.
Supports the establishment of appropriate testing in support of shelf-life determination of products (stability program).
Develop and maintain a high level of product, analytical, and process knowledge in both self and staff. Provides training to employees, as needed (new procedures, GMP training, technical training, etc.).
Provide Quality Systems support for new and custom product development including authorship/review of quality plans
Manages department spending and budgets.
Performance Metrics:
Capability and Capacity (Complaint Volume, On-time Complaint closure)
Customer Satisfaction (timely response to customer inquiries)
Cost (Department budget spending)
Culture (Training compliance)
Minimum of a 4-year degree in life sciences or engineering field with 4 years of related experience in either an aseptic processing or sterile products manufacturing facility
Successful and proven supervisory experience in a manufacturing or quality function
Solid computer knowledge in Microsoft Word and Excel
Must be detail oriented
Demonstrated ability to drive results within quality infrastructure
Demonstrated leadership capability; ability to influence others, act with integrity
Performance Excellence (Six Sigma) Green Belt
Familiarity with global regulatory requirements (Canadian, European, Japanese, Chinese)
Knowledge of 21 CFR 210/211, 21 CFR 820, 21 CFR 809.10(a)(2) and ISO 13485:2003
Familiarity with US DOT and Hazmat regulations

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