Corning is the world leader in specialty glass and ceramics, creating and manufacturing keystone components that enable high-technology systems.
Corning’s history is filled with breakthrough technologies that have played an important role in the way the world works. We thrive on solving difficult, commercially relevant problems through an innovative and collaborative research and development process. Corning succeeds through sustained investment in R&D, more than 160 years of materials science and process engineering knowledge, and a distinctive collaborative culture.
A world leader in industrial research and development, Corning staunchly believes in change. We thrive on seeking new opportunities to make a difference for mankind and bringing them to life.
Our dedicated scientists conduct their research with the highest integrity, finely tuned processes and superb skill. Breakthroughs occur when our researchers leverage existing technologies across product lines or come as the result of a profound moment of inspiration or even as an unexpected, experimental outcome. That is when research is at its most exciting.
We do everything possible to sustain our culture of innovation. We continually invest in research and development to provide our scientists with the resources they need. This has enabled our scientific community to develop a unique ability to solve complex problems and maintain a keen focus on things that really matter -- technologies that improve our lives and change our world.
R&D is the foundation on which Corning’s history has been built, and we have no doubt it will lead us to future technological triumphs.
To know more about Corning's Science and Technology division, please visit the R&D website at:
Scope of Position:
Develops, modifies, applies and maintains quality evaluation and control systems and protocols for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place that meet FDA, ISO, and other international medical industry expectations. Audits quality systems for deficiency identification and correction. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. Areas of specialization include: design, incoming material, production control, product evaluation and reliability, inventory control and research and development as they apply to product or process quality. Able to effectively train others on cGMP and explain the application of regulations in the design and manufacture of medical devices and products sold to drug manufacturers. Position location starts in Pittsburgh, PA with potential relocation to another location in the North East USA after 1-2 years.
Day to Day responsibilities:
- Works with procurement and the plant to resolve incoming material issues
- Liaison to customer on quality issues
- Implement containment and corrective actions
- Ensure plant adherence to QMS
- Champion for variation reduction and defect elimination
- Responsible for lab measurement equipment, procedures and performance
- Calculate and report quality metrics
- Develop and carry out experiments and validations
- Assist in identifying process control issues and resolution
- Capable of leading projects to identify root cause of issues and verifying that solutions are effective
- Provide direction and training in the area of cGMP, Quality Systems and Quality Assurance
- Develops and leads some areas of the manufacturing and/or technical roadmap for tubing
- Documents material, process and/or equipment to protect and contribute to Intellectual Property improvements
- Proficient in use of statistical data analysis and DOE in process problem solving and process/product improvement
- Works with Product Engineering and Development to define tubing specifications for new products
- Develops SME knowledge of tubing material, process and equipment
- Is a leader and Subject Matter Expert (SME) in process control/discipline, SPC, SQC, Designed Experiments, and other
- Performance Excellence processes (Greenbelt skills)
- Ensure approved specifications exist with rev for all tubing that is put in inventory
- Assemble, sign and maintain each lot’s Batch History Record
Required Education: Bachelor of Science or equivalent in tech field
Required Years and Area of Experience: 5 years + Manufacturing experience
- Knowledge and experience in the design and implementation of Quality Management Systems for regulated manufacturing of medical devices and products sold to drug manufacturers.
- Knowledge and experience in the design and execution of quality systems to meet ISO 9001.
- Training and experience as a quality auditor
- Supervisory experience
- Statistical knowledge and experience (SPC, DOE, t-test, ANOVA, capability analysis)
- Ability to challenge business to maintain compliance and determine what level of risk is acceptable
Desired and Soft skills:
- Drive for results
- Managing and measuring work
- Problem solving
- Project management
- Competence in technical field
- Technical learning
- Directing the work of others
- Excellent communication skills
Corning is an Equal Opportunity Employer. Minorities, women, veterans and individuals with disabilities are encouraged to apply.
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