Senior Supplier Quality Engineer

Overview

Senior Supplier Quality Engineer role at Johnson & Johnson Med Tech.

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We are searching for the best talent for Senior Supplier Quality Engineer to be located in Cincinnati, OH.

The Supplier Quality Engineers are responsible for supplier-related quality engineering activities in support of New Product Development and ongoing manufacturing. Supplier Quality Engineers have the opportunity to support activities associated with External Manufacturers, Direct Material (Component) Suppliers, and Indirect Service Suppliers.

• Issues resolution with suppliers – investigating challenging issues with significant business impact.
• Developing and maintaining suppliers – executing Supplier Reviews, audit related activities and deep dive Technical Assessments at suppliers.
• Development/negotiation of Quality Agreements with suppliers.
• Changing the way we do business – continuously improving our policies and procedures.
• Supplier process changes – assessing, documenting, validating, and leading or approving significant changes in supplier processes (including component approval activities).
• Stabilizing new products at suppliers – working with NPD and suppliers to ensure a smooth product launch from a supplier perspective, through both pre- and post-launch activities.
• The technical liaison, as needed, between product development, manufacturing, external manufacturers & suppliers.
• Provide leadership in design & implementation of world-class quality engineering to support the entire product life cycle with focus on quality engineering activities such as root cause analysis, corrective/preventive action, risk management, analytics/statistical techniques, verification & validation, and design control across the lifecycle of the product.
• Provide leadership and technical expertise to ensure supplier conformance to applicable ISO, FDA (Food & Drug Administration) & MDD (Medical Devices Directive) requirements.

• A minimum of a Bachelor's degree is required. A degree concentration in Engineering, Life Science, Physical Science and/or related is preferred. An advanced degree is preferred.
• A minimum of 2 years Quality/Manufacturing experience or related experience is required.
• Experience in the medical device, pharmaceutical or other highly regulated industry is preferred.
• Knowledge of ISO and/or cGMP regulations is preferred.
• Experience in a FDA regulated environment is preferred.
• An ASQ certification (CQE, CQM, CRE or CQA) is preferred.
• Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification is preferred.
• Basic knowledge in Statistics, Sampling Planning, Risk Assessment and Process Validation is preferred.
• It is required to be able to communicate effectively at all levels within Quality as well as cross functionally with departments such as R&D, Operations, Medical Affairs, Compliance, Manufacturing, etc.
• Auditing experience is preferred.
• Strong root cause analysis skills are required.
• Strong quality engineering skills with a proven track record in design verification/validation, process verification/validation, and effects analyses is strongly preferred.
• This position may require up to 10% domestic travel.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or…