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Job Function:

Supply Chain Engineering

Job Sub Function:

Quality Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Cincinnati, Ohio, United States of America

Job Description

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.

Key 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.

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 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.
• 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.

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 local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers .Internal employees contact AskGS to be directed to your accommodation resource.

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Required Skills

Preferred Skills: