Quality Assurance (QA) Manager, Operations Remote

Requisition Number: 67373

 

Corning is vital to progress – in the industries we help shape and in the world we share.

 

We invent life-changing technologies using materials science. Our scientific and manufacturing expertise, boundless curiosity, and commitment to purposeful invention place us at the center of the way the world interacts, works, learns, and lives.

 

Our sustained investment in research, development, and invention means we’re always ready to solve the toughest challenges alongside our customers. 

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.

Role Purpose

Manage and maintain the plants’ Quality Systems and all related activities to ensure that the products, both manufactured and purchased, meet customer and all applicable regulatory requirements. Promote continuous improvement methodologies for the Quality Systems and for the Manufacturing Operations.  Promote continuous improvement in customer satisfaction through inter-department communication, internal manufacturing specification understanding, sharing information, leadership of quality improvement projects

Key Responsibilities

• Manage and provide leadership to multiple LS manufacturing Quality organizations to ensure products meet both customer expectations and all applicable regulatory requirements. 
• Manage plant Quality Systems to be ISO 9001, ISO 13485, and 21 CRF Part 820 compliant, as needed.
• Management and resourcing of department project portfolio.
• Support the new product development process including plant resourcing, supplier/customer quality issue resolution.
• Drive department or regional project portfolio to meet immediate and ongoing business needs including ongoing management of department /regional Resources.
• Interface with Division Regulatory to understand and implement and country specific product requirements.
• Coach and develop direct employees in - responsibilities as well as identified developmental areas.
• Develop methods/metrics to evaluate and continuously improve process capability and effectiveness.
• Manage the technical aspects of projects involving key customer accounts.
• Meet annual objectives of permanent quality fixes.
• Travel required up to 50% – within North America

Requirements

• Bachelor’s Degree within technical discipline (Engineering or Life Sciences)
• Minimum of 10 years’ experience in Quality Assurance or Regulatory (preferably in a medical device regulated manufacturing environment) with 5 years of experience in a plant quality management role.
• Deep knowledge of ISO 9001, ISO 13485, 21 CFR Part 820, 210/211.
• Effective project management skills; experience in managing large-scale and/or multiple projects simultaneously.
• Organized; ability to prioritize and manage multiple activities to meet demanding production schedules and dynamic shipment requirements of each plant.
• Strong Communication skills, ability to effectively communicate and interact across all levels.
• Flexibility; ability to work in a dynamic environment while managing multiple priorities.
• Tactical /analytical thinking.
• High sense of urgency.
• Proficiency in MS Office applications (EXCEL, Access), Peoplesoft, Proficy.
• Previous statistical / quality experience (Gage R&R, Calibration familiarity).

Desired Skills

• Knowledge and familiarity of internal (and external) manufacturing specifications, process capability, quality systems, and quality architecture development.
• Basic understanding of Six S