Division Quality Engineer

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. 

Key Responsibilities:

• 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 (e.g. CAPAs, SCARs) 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 or 3rd party manufactured product for Corning which would include Supplier Selection and Qualification and Product Validation.
• Leveraging quality engineering best practices, champion and use standard product life cycle management systems, tools, and outputs:
  • Design & Development Controls
  • Product Verification & Validation
  • Process and Equipment Validation (e.g. IQ/OQ/PQ)
  • Product Quality Architecture (PQA)
  • Innovation
  • Manufacturing Innovation Excellence (MIE)
  • Manufacturing Scalability Playbook (MSP)
  • Other Performance Excellence (PEx) tools as appropriate (e.g. Six Sigma tools, FMEA, DoE, Measurement System Analyses, Gauge Repeatability & Reproducibility (R&R), DMAIC, Manufacturing Engineering Excellence (MEE), Lean, etc.)
  • Supplier Performance and Quality Management
• 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 (e.g. sterility, leachables/extractables, in vitro and in vivo toxicity, biological and chemical contamination sources and mitigation, etc.)
• Support in the creation of technical documentation that fits business needs and maintains compliance to applicable international standard and regulatory requirements (e.g. ISO, FDA, EU, etc.)
• Author Design History Files, customer-facing validation guides, change notifications/validation summaries, product certifications, and instructions for use literature

Experiences/Education - Required: 

• • 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.

   

  Skills:

  • Capable of the integration and application of user targeted manufacturing process documentation while meeting business and regulatory requirements.
  • Good understanding of Continuous Improvement/PEx Methodologies, including lean, six sigma, statistical applications and validation.
  • Working knowledge of relevant software for data collection (e.g. ERP, PI, eQMS), data storage and analysis (e.g. Microsoft Access, Microsoft Excel), project management (e.g. Microsoft Project), statistics (e.g. R, Minitab, JMP), word processing (e.g. Microsoft Word), reporting (e.g. Microsoft Visio, Mindjet MindManager, Microsoft PowerPoint), and communication (e.g. Microsoft Outlook, Microsoft Skype, Microsoft Teams, Microsoft SharePoint, Cisco WebEx).
  • Ability to work independently with strong time management and prioritization skills to handle multiple assignments and interact with product teams.
  • Ability to influence individuals without authority and to motivate others within a project team.
  • Ability to make data-derived decisions regarding product and process suitability and conformance.
  • Must be an effective communicator (written and verbal), highly organized, motivated, detail oriented with excellent analytical thinking and problem-solving skills.
  • Ability to lead projects and coordinate the efforts of others to complete project goals; must also possess the ability to effectively manage conflict.
  • Ability to lead change management and perform other duties as assigned. 

   

Experience Desired:

• 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.