Quality Engineer

Requisition Number: 63388

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 Plant Quality Manager.  This position focuses on sterility assurance, issue resolution, product and supplier quality, and process improvement.  We look for you to work closely with other functions within the organization (Engineering, Operations, Development and Procurement) and be responsible for driving an improved Customer experience with our products.

Day to Day Responsibilities:  

• Acting on site sterilization and microbiology subject matter expert
• Support customer and regulatory audits as sterilization and environmental monitoring expert
• Actively involved in new product validation and testing at the plant
• Coordinate, facilitate and direct daily quality control testing laboratory activities to ensure compliance to established laboratory process controls and operating procedures
• Ensure products are tested to meet release commitments
• Responsible for out-of-specification (OOS) investigations, root cause analysis, and continuous improvement initiatives
• Lead for review, investigation and resolution of customer complaints
• Lead for CLS help desk inquires owned by the plant
• Responsible for reporting, metrics and periodic review of data/issues to drive improvement
• Perform and review cell culture testing including plating efficiency, growth promotion, and confirmatory testing
• Inspect products at various stages of the production process to determine and maintain their quality and reliability as part of investigations
• Review biological/microbiological testing including sterility
• Perform and review environmental monitoring of manufacturing areas
• Achieve department requirements for safety, quality, product release, equipment uptime, sample throughput, and cost

Travel Requirements:  Limited travel may be required (5-10%)

Hours of work/work schedule/flex-time:  M-F / Typically 8 am - 5 pm; overtime support as needed (supporting a 24/7 facility)

Required Education:  Bachelor’s degree in Engineering, Technical or Natural Science field; advanced degree preferred, but not required.

Required Years and Area of Experience:  Minimum 5 + years quality control experience including sterility in medical or pharmaceutical business

Required Skills: 

• Previous Quality Control and sterility experience in a manufacturing or technical function
• Experience with internal and external auditing
• Demonstrated use of root cause and problem-solving skills to resolve technical issues
• Experience with procedure and work instruction development
• Project management experience
• Proficiency in Microsoft Office.
• Knowledge or experience with ISO 9001 and/or regulated products

Desired Skills: 

• Experience with Performance Excellence (Six Sigma) Green Belt or other
• Knowledge of ISO 9001, 21 CFR 820 and ISO 13485
• Demonstrated leadership experience in project management

Soft Skills:

• Excellent interpersonal, verbal, written and communication skills and focus on networking and relationship building
• Ability to interact with individuals from various cultural backgrounds, regions, and levels in the organization
• Ability to negotiate, influence, and lead

This position does not support immigration sponsorship.  

The range for this position is  $85,553.00   -  $117,636.00 assuming full time status. 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 are dependent on hours worked and may 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.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To request an accommodation, please contact us at accommodations@corning.com.