Corning Incorporated Division Quality System & Training Specialist in Tewksbury, Massachusetts
Division Quality System & Training Specialist
Date: Aug 3, 2018
Location: Tewksbury, MA, US, 01876
Req #: 31973
Corning is one of the world’s leading innovators in materials science. For more than 160 years, Corning has applied its unparalleled expertise inspecialty 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 Division Quality System & Training Specialist is responsible to support and assist management of Division Quality Systems, Training and EtQ system. You will participate in quality system projects and provides guidance and subject matter expertise on quality related topics.
Day to Day Responsibilities:
You will assist in developing and handling Quality System Metrics for Division and highlight areas of concern/opportunities for improvement.
We look for you to support and maintain Quality system processes including, Quality agreements, Field Actions, Internal audits and other processes as needed.
Lead tracking of CAPAs and performing the CAPA coordinator role.
Coordinate with Department Managers on Required Training in EtQ.
Maintain the Training in EtQ and monitor training on Documents in EtQ.
Collaborates functionally and cross-functionally to meet organization objectives and initiatives.
Support plants for implementation of Division quality management processes.
Document Control for Division.
Support third party audit.
Supports the supplier management program.
- Will travel less than 15% domestically or internationally.
Hours of work/work schedule/flex-time:
- Monday – Friday, 8am – 5pm, flexible with start times and may work from home 1 day/week depending on project timing.
- Bachelor’s degree required.
Required Years and Area of Experience:
- Minimum 2+ years of quality system management or quality compliance experience within the life sciences, medical device or a regulated industry.
Understanding and applying FDA’s Quality System Regulation and ISO 9001 and/or 13485 requirements for quality management systems, including leading and supporting CAPA investigations and/or related activities in other regulated environments.
Ability to use tools to uncover root causes and implement corrective actions.
Proficient in basic information technology tools including MS Word, Excel, PowerPoint.
Desired Experience / Qualifications / Skills:
Knowledge of LEAN, Six Sigma and statistical process control.
Prefer strong organization skills.
Project management skills.
You should have a strong instinct to act, customer-focused and skilled in decision-making, establishing relationships, problem solving, issue resolution, planning and organizing, and analytical thinking
Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.
Do you have effective written and verbal skills across all levels of the organization and ability to deliver messages through presentations?
Do you possess the ability to handle multiple tasks concurrently timely?
Ability to work effectively and efficiently in a team environment to accomplish goals.
We look for you to display eagerness to learn and continuously improve.
Positive work attitude that supports collaboration and continuous improvement.
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.
Nearest Major Market: Boston