Senior Supplier Quality Engineer

Johnson & Johnson Innovative Medicine • Cincinnati, OH

1d • Hybrid

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. We are searching for the best talent for Senior Supplier Quality Engineer to join our Ethicon Endo-Surgery organization located in Cincinnati, OH. The Ethicon Endo-Surgery business offers a broad range of products, platforms and technologies, including surgical staplers, clip appliers, trocars and tissue sealing 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. Ethicon Endo-Surgery, Inc. was created 30 years ago in Cincinnati, Ohio, developing innovative devices that have driven the revolutionary shift from open to minimally invasive surgery that continues to lead industry today. 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.

Requirements

• A minimum of a Bachelor's degree is required.
• A minimum of 4-6 years Quality/Manufacturing experience or related experience is required.
• 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.
• Strong root cause analysis skills are required.

Nice To Haves

• A degree concentration in Engineering, Life Science, Physical Science, comparable work experience, or a related field is an asset.
• An advanced degree is preferred.
• Experience in the medical device, pharmaceutical or other highly regulated industry is preferred.
• Knowledge of ISO and/or cGMP regulations is preferred.
• Experience in an 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.
• Auditing experience is preferred.
• Strong quality engineering skills with a proven track record in design verification/validation, process verification/validation, and effects analyses is strongly preferred.

Responsibilities

• 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.

What This Job Offers

• Career Level: Senior
• Number of Employees: 5,001-10,000 employees