Senior Supplier Quality Engineer; Indirect Materials

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 Med Tech, 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.

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Supply Chain Engineering

Quality Engineering

Scientific/Technology

Cincinnati, Ohio, United States of America, Ciudad Juarez, Chihuahua, Mexico, Guaynabo, Puerto Rico, United States of America

Ethicon Endo-Surgery is recruiting for a Senior Supplier Quality Engineer (Indirect Materials), located in either Cincinnati, OH, Juarez, Mexico or Guaynabo, PR.

Remote work options may be considered on a case-by-case basis and if approved by the company.

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at

The position of Supplier Quality Engineer is responsible for support and leadership of Quality Engineering activities in New Product Development and ongoing manufacturing – including resolution of non-conformances (root cause & corrective action), CAPA, Quality System and process improvement activities

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

United States & Puerto Rico - Requisition Number: R-059974

Mexico – Requisition Number: R-061123

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

• Provide leadership in design i& implementation of world-class quality engineering to support entire product life cycle with focus on quality engineering activities such as reliability, root cause/corrective action risk management, analytics/statistical techniques, requirements management, verification & validation, and design control across the lifecycle of the products.
• Activities include driving correction, corrective action, prevention, detection of defects at earliest phase of product design, continuous improvement & customer satisfaction.
• Provide leadership and technical expertise to ensure conformance to ISO, FDA (Food & Drug Administration) & MDD (Medical Devices Directive) based quality systems.
• Provide review and approvals for the release of new products ensuring quality requirements are met.
• Provide leadership & support to J&J process excellence initiatives including Six-Sigma, design excellence & lean thinking.
• Direct development & consistent application of quality policies & procedures in product design & development, secondary development, manufacturing, external manufacturers & suppliers.
• Responsible for following and administering safety.
• Compliance with safety policies and procedures.
• Follow J&J and EES Records Management Policies for Convenience Information, Records Retention Schedules, Training and Education, Document Hold Notices, Records Cleanout, Inactive Records and Information Management, Vital Records and third party vendor if applicable.
• Other responsibilities may be assigned and not all responsibilities listed may be assigned
• Responsible for communicating business related issues or opportunities to next management level.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.

• Performs other duties assigned as needed.

Education:

• Bachelor or equivalent university degree is required. Bachelor of Science in Engineering or Applicable Sciences preferred.

Experience and Skills:

Required:

• 3-4 years of related work experience
• Experience in a regulated industry (Medical, automotive, aerospace, etc.)
• Regulatory compliance knowledge: GMP, MDD (Medical Devices Directive), 510K (Pre-market approval), and Government, trade association, industry & medical publications
• Communication (written and verbal)
• Negotiation / influencing
• Quality Assertiveness
• Analytical & Creative thinking
• Project Management skills to support multiple projects simultaneously
• Problem-solving & priority setting
• Organizational &…