Senior Supplier Quality Engineer (Indirect Materials)

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

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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.

About MedTech

Fueled by innovation at the intersection of biology and technology were 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 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.

Key Responsibilities:

• 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.

Qualifications

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 & integral-synthesize information from a variety of sources
• Understand concepts quickly
• Research and maintain ongoing learning of industry and regulations
• Experience with Microsoft Office (Windows)

Preferred:

• Experience working with suppliers

Other:

• Preferred certifications: CQA CQE CRE Six Sigma GB or BB
• English proficiency required

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 Internal employees contact AskGS to be directed to your accommodation resource.

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