QA Operations NPI Lead

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:

Yokneam, Haifa District, Israel

Job Description:

About Cardiovascular

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

Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.

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 QA Operations NPI Lead to be in Yokneam.

The QA Operations NPI Lead is responsible for leading new product introduction and design transfer activities:

Establish and lead Quality activities for new product introduction to operation until the product/process stabilization
Provide and communicate quality operation deliverables and inputs in early development stages and actively participate in development teams and serve as focal point from QA Operation, supporting the transfer to production activities
Verifies product / Test equipment /process Compatibility and readiness for production
Review and analyze quality trends with the operation team until new product/process stabilization
Support robust key production processes ( pFMEA , Control Plan , CTQ )
Manage Process validation/ Verification activities

Education & Experience:

BSc in Engineering or Practical Engineering with Qualification in Quality Assurance (CQE, CQM or CQA).
Practical knowledge of ISO13485 , Experience in medical system or medical device companies
Demonstrated knowledge of manufacturing principles and practices, and procedures.
Experience with validations (IQ/OQ/PQ/TMV) and supplier management
Experience with Leading multidisciplinary project and processes
Understanding of drawings, specifications, and electrical schemes (an advantage)

Skills:

Project management, problem solving
Good communication skills, both verbal and written in English.
Good interpersonal relations.
Reliable and accurate.
Good sense of urgency.

#LI-LM5

Required Skills:

Preferred Skills:

Coaching, Consistency, Controls Compliance, Critical Thinking, Data Savvy, Engineering, Financial Competence, Good Automated Manufacturing Practice (GAMP), ISO 9001, Lean Supply Chain Management, Leverages Information, Process Improvements, Quality Control (QC), Quality Standards, Quality Systems Documentation, Quality Validation, Science, Technology, Engineering, and Math (STEM) Application, Technologically Savvy