Quality Engineer

Requisition Number: 61532

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.

Scope of Position:

In this role you will be reporting directly to the Quality Engineering Supervisor. 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. You will work closely with other functions within the organization (Manufacturing, R&D, CI, Quality, Engineering, Procurement and Marketing) and will be responsible for the quality of the product and process for the assigned product line(s).

Required Qualifications:  

• Bachelor’s degree Engineering or Statistics preferred.
• Manufacturing quality engineering experience in a highly regulated industry (medical device industry preferred.)
• Capable of the integration and application of user aimed manufacturing process documentation while meeting business and regulatory requirements.
• Demonstrated technical writing skills.
• Working knowledge of databases, spreadsheet applications, and word processing, to perform necessary tasks for preparing required data analysis, reports, documents and general communication.
• Ability to work independently with strong time management and prioritization skills to handle multiple assignments and interact with product teams.
• Ability to make decisions regarding product disposition and corrective and preventive action effectiveness.
• Able to give direction to accomplish work you're leading.
• Good understanding of Continuous Improvement Methodologies, including lean, six sigma, statistical applications and validation.

Day to Day Responsibilities:

• We look for you to provide product team support including, Material Review Board (MRB), customer complaint activities, statistical analysis, validation support, inspection plans, metrology, quality metrics and report functions.
• Provide Life Sciences help desk and customer complaint point of contact and problem resolution to include Questionnaires, Certificates, and Customer Surveys etc.
• Facilitate investigations, Situation Analysis (SA) and Health Hazard Evaluation (HHE) with clear documentation of corrective actions.
• Lead discussions on blocked stock and open notifications in Material Review Board (MRB).
• Support Life Sciences Corporate (Tewksbury) with Customer Notification Letters from plant projects as needed.
• Assist with the investigation of Corrective & Preventive Actions (CAPA), notifications and customer complaints, providing solutions where possible. Communicate customer feedback to Quality Systems group.
• Work with functional groups to ensure changes proposed through the change management program have the proper technical review and that there is a risk assessment of requested changes.
• 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 Continuous Improvement activities and key plant projects.
• Focus on cost avoidance and cost reduction activities that will contribute to a reduction in poor cost of quality (COQ).
• Develop/Revise Quality Plans including incoming, in-process and final inspection, and provide training to those affected by the plans.
• Implement validated inspection and metrology improvements and associated training.
• Review and approve Project Design History Files.
• Create technical process documents that fit the business needs and maintain compliance to the regulatory requirements of the FDA and ISO standards.
• Serve as a resource for performing internal audits to ensure quality system compliance.
• Able to react to change and perform other duties as assigned.

Desired Qualifications:

• Thorough knowledge of the regulatory industry requirements ISO9001 or ISO13485 and Quality Systems Regulation CFR 21 part 820, GDP / GMP-Good Doc / Good Manufacturing Practices.
• ASQ Certified Quality Engineer
• ERP system experience; prefer PeopleSoft.

Soft Skills:

• Action oriented, can make informed decisions, self-motivated, capable of influencing without authority. Collaborative with strong initiative and positive mindset.
• Effective communicator (written and verbal), highly organized, motivated, detail oriented with excellent analytical thinking and problem-solving skills.

This position does not support immigration sponsorship.  

The range for this position is $69,156.00 - $95,090.00.  Starting pay for the successful applicant is dependent on a variety of job-related factors, including but not limited to geographic location, market demands, experience, training, and education. The benefits available for this position include medical, dental, vision, 401(k) plan, pension plan, life insurance coverage, disability benefits, and PTO.

​Corning Puts YOU First! 

We are committed to supporting your health, financial, career development, and life goals as you grow professionally and personally to achieve your highest potential. All benefits begin as soon as you start your career at Corning.  

• Our monetary peer-to-peer recognition program is tied to our Values and celebrates you and your colleagues’ contributions. 
• Health and well-being benefits include medical, dental, vision, paid parental leave, mental health/substance use, fitness, and disease management programs.  
• Financial benefits include a 401(k) savings plan with company matching contributions and a 100% company-paid pension benefit that grows steadily throughout your career. 
• Companywide bonus and attractive short- and long-term compensation programs are available based on your role and responsibilities.   
• Professional development programs help you grow and achieve your career goals.

We prohibit discrimination on the basis of race, color, gender, age, religion, national origin, sexual orientation, gender identity or expression, disability, veteran status or any other legally protected status.