Quality Engineer

Corning - Corning, NY (30+ days ago)4.0

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.

The position, reporting to the CM Quality Manager, will apply Quality Engineering principles to the Contract Manufacturing business, to investigate, analyze, and resolve product quality defects with the intent of optimizing the customer experience. Additionally, proactive work will include supporting new product teams to insure that the products are defined and tested such that they’ll perform as expected in the customer’s intended application. The candidate will establish themselves as a credible key technical resource within Life Sciences and work with other functions – Supplier Management, Regulatory, and Commercial – to complete the Quality Engineering mission.

Duties & Responsibilities:
  • Engage with Suppliers to insure clear and documented requirements are declared and understood
  • Drive to root cause understanding of product defects and needed corrective actions to address Quality issues
  • Be an advocate and active participant of Quality Systems processes including SCARs, Complaint Management, and CAPAs
  • Active participant in audits including Supplier Audits and Internal Improvement audits
  • Insure data, and statistical evidence exists to support any external claims made on products
  • Act as CM’s primary regulatory contact, working with Division resources, to insure compliance with applicable regulatory and industry oversight bodies
  • Lead effort to drive Complaint metrics to desired performance
  • Participate or lead team efforts aimed at Continuous Improvement using Six Sigma, Lean, FMEA or other proven methodologies
  • Serve as the Quality lead on new product introduction projects (RAPID, customs and specials, etc.). • Develop and execute Quality/Validation Plans and coordinate and execute inspections.
  • Support new supplier introduction and supplier consolidation.
Travel: <30%

  • Bachelor’s Degree in Life Sciences or Engineering.
  • ASQ Certifications (CQA / CQE / CMQOE) preferred
Required Experience:
  • Minimum of 5 years of related experience
  • 3+ years of experience in Pharmaceutical / Medical Device and/or Laboratory Equipment industry
  • 2+ years of experience in quality auditing
  • Familiarity with FDA regulations, ISO9001 & ISO13485
  • Strong knowledge base in Quality including validation, calibration, quality control
  • Ability to apply Statistical techniques to drive improvement activities
  • CQE certification
  • Certified Six Sigma Belt
  • Medical device manufacturing and sterilization background, preferably including sterile pharmaceutical processes.
Other Required Qualifications:
  • Excellent interpersonal skills are required to interact with a broad range of associates at various levels of the organization.
  • Knowledge of processes and practices of other disciplines which interface with Quality.
  • Knowledgeable in Microsoft Office tools, Electronic Document Management Systems
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.