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Quality Engineer & System Lead

Date: Jun 13, 2019

Location: Bedford, MA, US, 01730

Company: Corning

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:

In this role, you will be working out of the Bedford and Woburn, MA offices, the Quality Engineer and System Lead is responsible for ensuring compliance to the Corning site manufacturing processes according to ISO 9001 standards and to the quality system, and managing compliance of required permits and licenses at the plants. You will be responsible for implementing, maintaining and monitoring Quality processes. This position involves product 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. We look for you to supervises one or more quality team members. You will also work closely with other functions within the organization (Manufacturing, R&D, PEx, Quality, Engineering, Procurement and Marketing) and will be responsible for ensuring quality of the product and alignment to processes.

 

Day to Day Responsibilities:

  • Plans and manages the work for the quality system team and provides technical leadership to ensure all necessary quality goals are completed on time, and according to procedures.
  • Provide product support including, Material Review Board (MRB), customer complaint activities, statistical analysis, validation support, inspection plans, quality metrics and report functions.
  • Point of contact for quality help desk and customer complaints. Ensures responses for requests: Questionnaires, Certificates, and Customer Surveys etc.
  • Facilitate and support the investigation of Non-conformances, Failure Investigation Reports (FIR), Corrective & Preventive Actions (CAPA) and Situation Analysis (SA) with clear documentation of corrective actions.
  • Lead discussions on blocked stock and open notifications in Material Review Board (MRB).
  • Responsible for coordinating and leading Executive Steering Committee (ESC) and CAPA Review Board meetings.
  • Support Life Sciences Corporate (Tewksbury) with Customer Notification Letters from plant projects as needed.
  • Ensure completion of customer complaints investigations, providing solutions where possible, and ensuring responses are provided on time. Communicate customer feedback to Quality Systems group.
  • Apply quality engineering practices and guidance to support project teams and manufacturing operations using Six Sigma tools, FMEA, CE Diagram, CE Matrix, DOE, MSA, Validation Protocol development, review, approval and Control Plans.
  • Support/Lead Continuous Improvement activities/projects and key plant projects.
  • Develop/Revise Quality Plans including: incoming, in-process and final inspection, and provide training to those affected by the plans.
  • Active participant on new product development teams. Review and approve Project Design History Files and PQA documents.
  • Create technical process documents that fit the business needs while maintaining compliance to the regulatory requirements of the ISO standards.
  • Serve as a resource for performing internal/external audits to ensure quality system compliance.
  • Prepares for and coordinates customer and regulatory audits.
  • Able to react to change and perform other duties as assigned.

 

Travel Requirements:

  • Some travel may be required for auditing purposes.

 

Hours of work/work schedule/flex-time:

  • 40 hours, Monday to Friday, standard business hours.

 

Required Education:

  • Bachelor’s degree from an accredited institution in a scientific, engineering or technical discipline.
  • Biotechnology, Chemistry or Microbiology preferred.

 

Required Years and Area of Experience:

  • Minimum of 3+ years of work experience in quality assurance and/or quality systems in a highly regulated manufacturing environment.
  • Minimum 2 years of leadership and project management experience.

 

Required Skills:

  • Related work experience auditing (internal/supplier).
  • Root cause analysis and problem-solving abilities.
  • Working knowledge of databases and word processing, to perform necessary tasks for preparing data analysis, reports, documents and general communication.
  • Knowledge of manufacturing processes and relevant statistical methods for quality assurance.
  • 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.
  • Thorough knowledge of Quality Management Systems and regulatory industry requirements (ISO9001, GDP / GMP / Good Manufacturing Practices).
  • Understanding of Manufacturing of biologics.
  • Demonstrated ability to execute against the strategic and tactical objectives provided by senior leaders both within Quality and outside of the function.
  • Strong understanding and appreciation for regulatory requirements, quality and compliance.
  • Ability to train and develop self and others.

 

Desired Experience / Qualifications / Skills:

  • Six Sigma Green/Black Belt certified preferred.
  • ASQ Certified Quality Engineer desired.
  • Design Control experience desired.
  • Lead auditor certification/experience.

 

Soft Skills:

  • Ability to make decisions regarding product disposition and corrective and preventive action effectiveness.
  • Ability to give direction to accomplish tasks.
  • Ability to work independently with strong time management and prioritization skills to handle multiple assignments and interact with product teams.
  • Strong team leadership and coaching skills.
  • Strong ability to communicate.
  • Strong ability to influence in a team environment and collaborate with peers.
  • Ability to prioritize different projects and be adaptable to change.

 

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