Senior Supplier Quality Engineer

Johnson & Johnson • Cincinnati, OH

17h • 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. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world, providing an inclusive work environment where each person is considered as an individual, respecting their diversity, dignity, and recognizing their merit. This role is for a Senior Supplier Quality Engineer to join the Ethicon Endo-Surgery organization 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, used in various 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. The Senior Supplier Quality Engineer will act as a technical liaison between product development, manufacturing, external manufacturers, and suppliers. They will provide leadership in the design and implementation of world-class quality engineering to support the entire product life cycle, focusing on activities such as root cause analysis, corrective/preventive action, risk management, analytics/statistical techniques, verification & validation, and design control. The role also involves providing leadership and technical expertise to ensure supplier conformance to applicable ISO, FDA (Food & Drug Administration), and 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.
• Ability 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. is required.
• 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

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees