QA Operations Lead

Reposted 4 Days Ago
Be an Early Applicant
Yokneam, ISR
In-Office
Mid level
Healthtech • Pharmaceutical • Manufacturing
The Role
The QA Operations NPI Lead manages quality activities for new product introductions, oversees quality deliverables, and leads validation processes while collaborating on design transfers and quality improvements.
Summary Generated by Built In

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 jnj.com.

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.

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 Johnson & Johnson MedTech 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 Lead role, to join our team located in Yokneam, Israel.

You will be responsible for:

  • 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  

Qualifications and Requirements:

  • 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 (such as SMT, wave, testing), 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)

  • Project management, problem solving  

  • Good communication skills, both verbal and written in English

#LI-AB6#LI-Hybrid



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

Top Skills

Iq/Oq/Pq/Tmv
Iso13485
Lean Supply Chain Management
Quality Assurance
Quality Control
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The Company
HQ: New Brunswick, NJ
143,612 Employees
Year Founded: 1886

What We Do

Profound Change Requires Boldness. Johnson & Johnson is the largest and most broadly based healthcare company in the world. We’re producing life-changing breakthroughs every day, and have been for the last 130 years. The combination of new technologies and your expertise enables amazing things to happen. Teams from J&J’s consumer business are creating digital tools to help people track the health of their skin. Those working in medical devices are 3-D printing artificial joints personalized for each patient, while researchers in pharmaceuticals use AI to discover lifesaving drugs. Imagine what the rest of our team of 134,000 people at 260 companies in more than 60 countries across the world is accomplishing. We redefine what it means to be a big company in today’s world. Social Media Community Guidelines: http://www.jnj.com/social-media-community-guidelines

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