Staff 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:

Quality

Job Sub Function:

Supplier Quality

Job Category:

Professional

All Job Posting Locations:

San Jose, California, United States of America

Job Description:

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

We are searching for the best talent for Staff Supplier Quality Engineer to be located at San Jose, CA.

The Staff Supplier Quality Engineer provides overall quality assurance leadership in the management and qualification of supplier and/or external manufacturers (EMs) for pre- and on-market product for RAD Monarch. Establishes and maintains quality assurance programs, procedures, and controls, ensuring that performance metrics of both the supplier quality systems and suppliers are continually measured to drive improvement initiatives. This position aids in the identification and elimination of supply chain risks via internal and supplier partnerships. Leads/participates in supplier/EM engagements to assess technical competency and general compliance to requirements, i.e., material specifications, CTQs, process control plans, and quality agreements. Key areas of focus within supplier management are leading supplier & process qualifications, leading issue/defect resolution, managing performance monitoring/reporting, compliance to J&J standards, and streamlining processes. Key areas of support provided to team members include risk management/communication, defect resolution, process capability/process improvement, and quality assurance general support.  Adheres to environment policy, procedures, and supports department environmental objectives.

You will be responsible for:

• Performs quality processes including change control, supplier nonconformance, quality agreements.  Participate in local site supplier/EM quality meetings to ensure communication and alignment of quality initiatives/objectives.  Lead supplier/EM quality evaluations.  Provide third party inspection support. 
• Lead defect resolution, root cause investigation, and continuous improvement activities.  Collaborate across functions to confirm if nonconformances are supplier/EM related as applicable.
• Support internal and/or external cross-functional and cross-sector project teams driving supplier/EM improvement and general initiatives through reducing variations in supply chain, institute control plans, and improving process capability.  Provide Quality Engineering support to suppliers/Ems including verification/validation activities.  Apply Quality Engineering tools such as Failure Mode & Effects Analysis (FMEA), Fault Tree Analysis (FTA), Root Cause Analysis, Design of Experiments (DOE) et., to the development of new products or processes related to raw materials, services, and finished products. 
• Accountable, as applicable for compliance in accordance with regulations. 
• Maintain, support compliance of, and improve supplier/EM quality processes, including procedural and electronic systems.  Support alignment with enterprise standards and executing gap assessment.  Provide regulatory guidance and interpretation to internal and external partners with regards to the following areas: EM and Supplier Quality procedures and medical devices. 
• Participate in decisions that are aligned with management objectives regarding work processes, plans, and schedules to achieve department objectives.
• Tracks and report progress across projects and department commitments by reviewing schedules and due dates, identifying risks, and assisting teams with contingency plans.

Qualifications

Education:

• Bachelor’s Degree in Engineering or related science/technical field