QA/QC Engineer II

This position uses industry best practice and statistically-justified quality engineering principles for creation and maintenance of product quality architecture commensurate to ever-evolving customer and business needs. This includes, but is not limited, to all stages of Innovation, Design and Development Controls, and Product Lifecycle Management.

This position works closely with other functions within the organization (Manufacturing, R&D, Quality, Engineering, Procurement, Supplier Management, and Business Operations) to lead a standardized, strategic life cycle management approach for Corning Life Science product lines. 

• Support the standardization of quality engineering systems, architecture, and specifications across Division manufacturing facilities
• Support actions for streamlined validation processes to ensure conforming, compliant product is made available to customers in a timely manner
• Participate in problem solving and root cause analysis activities internally and with suppliers and customers to eliminate recurrence of nonconformances and ensure continuity of supply
• Conduct supplier audits as needed to meet requirements
• Support actions to drive process standardization, waste elimination, and continuous improvement with suppliers
• Conduct division/customer/3rd party audits of internal sites as required
• Actively support new product launches for products manufactured by Corning
• Lead Quality projects of moderate scale and complexity
• Participate in and sometimes lead Quality lead on projects of major scale and complexity
• Supporting Quality lead on projects of major scale and complexity
• Provides technical guidance to cross-functional team members
• Proficient on industry-relevant customer expectations 
• Support in the creation of technical documentation that fits business needs and maintains compliance to applicable international standard and regulatory requirements
• Author Design History Files, customer-facing validation guides, change notifications/validation summaries, product certifications, and instructions for use literature
• Some travel is required as part of the job responsibilities.

• BS Degree in an engineering, scientific, or statistical field
• Minimum of 2-5 years of manufacturing quality or related engineering experience.
• 2-5 years of experience in validation application.
• In depth knowledge of applicable and similar industry requirements (e.g. ISO 9001, ISO 13485, ISO 15378 Quality Systems Regulations 21 CFR part 820, EU IVDR and MDR)
• Knowledge of manufacturing processes and relevant statistical methods for quality assurance.

• Life Science or Pharmaceutical Packaging product application knowledge and experience.
• Injection Molding manufacturing process knowledge and experience.
• Certified Quality Engineer recognition by ASQ.
• Certified Green or Black Belt recognition by ASQ