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Corning Incorporated · 2 hours ago

Division Quality Engineer

Corning, NY

Full-time

Onsite

Entry, Mid Level

$79K/yr - $109K/yr

2+ years exp

Corning Incorporated is a leading innovator in glass, ceramic, and materials science. The Division Quality Engineer position focuses on applying quality engineering principles to maintain product quality architecture and works collaboratively with various functions to ensure compliance and streamline processes.

Manufacturing

No H1B

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

Qualification

Quality Engineering PrinciplesValidation ApplicationISO Standards KnowledgeContinuous Improvement MethodologiesStatistical MethodsProject Management SoftwareAnalytical ThinkingTeam CoordinationEffective CommunicationProblem-Solving SkillsTime Management

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

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

Preferred

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

Benefits

Company-wide bonuses and long-term incentives align with key business results and ensure you are rewarded when the company performs well.

We provide a 100% company-paid pension benefit with fixed contributions that grow throughout your career.

Combined with matching contributions to your 401(k) savings plan, Corning’s total contributions to your retirement accounts can reach between 7% and 12% of your pay, depending on your age and years of service.

Our health and well-being benefits include medical, dental, vision, paid parental leave, family building support, fitness, company-paid life insurance, disability, disease management programs, paid time off, and an Employee Assistance Program (EAP) to support you and your family.

That’s why Corning offers a recognition program to celebrate successes and reward colleagues who make exceptional contributions.