Plant Quality Manager

Corning is one of the world’s leading innovators in materials science. For more than 160 years, Corning has applied its unparalleled expertise in specialty glass, ceramics, and optical physics to develop products that have created new industries and transformed people’s lives.

Corning succeeds through sustained investment in R&D, a unique combination of material and process innovation, and close collaboration with customers to solve tough technology challenges.

As a leading developer, manufacturer, and global supplier of scientific laboratory products for 100 years, Corning’s Life Sciences segment collaborates with researchers seeking new approaches to increase efficiencies, reduce costs and compress timelines in the drug discovery process. Using unique expertise in the fields of materials science, surface science, optics, biochemistry and biology, the segment provides innovative solutions that improve productivity and enable breakthrough discoveries.

Scope of Position:

The Plant Quality Manager is accountable for product and process compliance to regulatory, customer and Corning Life Sciences standards. Directs, plans and implements plant policies and procedures relating to Quality consistent with Divisional and Corporate Quality/Regulatory programs and policies and ensures compliance with regulatory requirements. Responsible for ensuring that a quality system is established, implemented and maintained in accordance with ISO 9001 and/or ISO13485 and QSR CFR Title 21, Part 820. Plans, organizes, directs and coordinates all activities related to the management of product, process, and service quality. As a member of the management group, this position is responsible for the development of individual and organizational strategies. Responsible for reporting on the performance of the quality system to the Plant Leadership Team and identifying improvement strategies. Collaborates with Engineering and Operations to plan plant activities and projects that achieve process, quality, and cost improvement through Performance Excellence. Selects and develops competent employees to implement the activities of the Quality organization. Collaborates with the Commercial group to resolve customer complaints and to translate customer requirements into meaningful product specifications.  Acts as the plant “Management representative” for notified bodies and liaison with regulatory authorities and customers, by hosting related audits and ensuring effective resolution of nonconformities.

 

Day to Day Responsibilities:

  • Manage plant quality systems (including ISO documentation, records retention, etc.) and plant quality personnel to ensure that the plant’s products meet all customer requirements. Responsible for ensuring regulatory compliance to all aspects of ISO 9001 and/or ISO13485 and 21 CFR 820 and all applicable regulations and guidance documents.
  • Leads the Quality Management Team consisting of Quality Assurance, Quality Engineering, and Quality Control leads
  • Responds quickly and effectively to customer complaints and issues. Serves as the customer advocate in the plant.
  • Collaborates with plant and division innovation teams to evaluate new product needs and translate them to meaningful plant specifications. Identifies and defines all required measurement protocols.
  • Works with process and product improvement teams regarding key product attributes to develop appropriate control strategies and feedback loops to make sure product attributes perform as expected.
  • Drive Performance Excellence activities to quickly and effectively support improvement initiatives. 
  • Develop and maintain a high level of product, analytical, and process knowledge in both self and staff.
  • Continuously improves quality function spending to help the plant lower its costs.
  • Manages department spending and budgets.
  • Perform process capability analysis as needed.
  • Provide statistical design and analysis services to internal plant departments.
  • Oversees FDA, ISO and Customer audits and ensures responses to these audits are provided in a timely fashion.
  • Review and acts as company representative for Quality and Supplier Agreement documents.
  • Oversees the validation program and is responsible for risk management.
  • As site regulatory lead, provides regulatory approval for the manufacture of custom products; gathers necessary information regarding intended use of product and regulatory approval for development and labeling of new products and regulatory approval for all documents-both technical/marketing and controlled documents as needed.
  • Responsible for all regulatory training and oversees the training program as it applies to cGMP and ISO requirements.
  • Responsible for performing duties as the site management representative per regulatory and ISO standards.

 

Travel Requirements:

Company
Corning
Posted
03/27/2018
Type
Full time
Location
Manassas, Virginia 20110, US