Sr Supplier Quality Engineer

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. Learn more at https://www.jnj.com

Job Function:

Supply Chain Engineering

Job Sub Function:

Quality Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

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

Job Description:

Ethicon Endo-Surgery is recruiting for a Senior Supplier Quality Engineer. The preferred location is Cincinnati, OH. However, the position can also be in Juarez, Mexico or Guaynabo, Puerto Rico.

About MedTech

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 https://www.jnj.com/medtech

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

Key Responsibilities:

• Provide leadership in design & 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 the 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:

• A Bachelor or equivalent degree in Engineering or applicable sciences is required. Other Bachelor/Master degrees acceptable with applicable work experience in a regulated industry.  Electrical Engineering Degree preferred.

Experience and Skills

Required:

• 2-4 years of related work experience
• Regulatory compliance knowledge: GMP, MDD (Medical Devices Directive), 510K (Pre-market approval), and Government, trade association, industry & medical publications
• Strong communication skills (written and verbal)
• Negotiation and influencing skills
• Effective assertiveness and quality assurance
• Analytical and creative thinking abilities
• Project management skills to handle multiple initiatives concurrently
• Problem-solving and prioritization capabilities
• Strong organizational skills and ability to synthesize information from diverse s