Ethicon, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Supplier Quality Engineer to be located in Cincinnati, OH or Juarez, MX.
The Ethicon business offers a broad range of products, platforms and technologies—including sutures, surgical staplers, clip appliers, trocars and synthetic mesh devices—that are used in a wide variety of minimally invasive and open surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women’s health conditions, hernias, cancer and obesity. The Ethicon business combines products and services of two market leading legacy companies, both with long histories of medical innovation. Ethicon, Inc. based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and electiveness of open surgery. Ethicon Endo-Surgery, Inc. was created 20 years ago in Cincinnati, Ohio, developing innovative devices that have driven the revolutionary shift from open to minimally invasive surgery that continues to lead the industry today.
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.
Responsibilities of the Senior Supplier Quality Engineer may include the following:
- Issues resolution with suppliers – investigating challenging issues with significant business impact.
- Developing and maintaining suppliers – executing Supplier Business 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 Senior Supplier Quality Engineer will act as technical liaison, as needed, between product development, manufacturing, external manufacturers & suppliers. They will 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. The Senior Supplier Quality Engineer will also provide leadership and technical expertise to ensure supplier conformance to applicable ISO, FDA (Food & Drug Administration) & MDD (Medical Devices Directive) requirements. Qualifications
- A minimum of a Bachelor's degree is required. A degree concentration in Engineering, Life Science, Physical Science, comparable work experience, or a related field is an asset. An advanced degree is preferred.
- A minimum of 4-6 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 can be located in Cincinnati, OH or Juarez, MX and may require up to 25% of both international and domestic travel.
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J2W: LI NAPrimary Location
United States-Ohio-CincinnatiOther Locations
Ethicon Endo Surgery Inc (6041)Job Function
Quality (Eng)Requisition ID