NPD Quality Engineer
Johnson & Johnson
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 EngineeringJob Sub Function:
Quality EngineeringJob Category:
Scientific/TechnologyAll Job Posting Locations:
Yokneam, Haifa District, IsraelJob 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 NPD Quality Engineer to be in Yokneam.
We are seeking a Quality Engineer with 3–5 years of experience to join our Class III Quality team. This unique role combines two core functions:
Design Transfer QA – Lead and coordinate quality activities during the transfer of Class III medical devices from R&D to production.
Computerized Systems Validation (CSV) – Plan and execute validation activities for non-product GxP computerized systems (e.g., Polarion, eDHR, Windchill, and software tools used for product testing).
This position requires ownership, proactive problem-solving, and collaboration with cross-functional teams in a regulated medical device environment.
Key Responsibilities
- Ensure compliance with ISO 13485, ISO 14971, FDA, and EU regulations during product development and design transfer.
- Lead risk management activities (e.g., FMEA) and quality investigations.
- Coordinate quality activities for new product introduction and design changes.
- Develop and approve validation plans and protocols for GxP systems and testing tools.
- Execute validation activities in compliance with SDLC, FDA 21 CFR Part 11, and EU Annex 11.
- Collaborate with R&D, Manufacturing, Regulatory Affairs, IT, and Supply Chain to ensure smooth design transfer and validation processes.
- Support internal audits and preparation for external audits.
- Drive continuous improvement initiatives in QA and CSV processes.
Qualifications
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Education:
- BSc in Engineering, Quality Assurance, Computer Science, or related field (preferred).
- Quality certifications (CQE, CSQE, CQM, CRE) – an advantage.
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Experience:
- 3–5 years as a Quality Engineer and/or CSV specialist in a regulated environment (medical devices preferred).
- Hands-on experience with design transfer and risk management.
- Practical experience in validation of GxP systems and software tools.
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Skills:
- Strong knowledge of ISO 13485, ISO 14971, FDA 21 CFR Part 11, EU Annex 11.
- Excellent communication and interpersonal skills.
- Ability to work independently and lead small projects.
- Proficiency in English (written and spoken).
- Detail-oriented with strategic thinking and problem-solving abilities.
Additional Information
- Reports to: Class III QA Team Leader
- Interfaces with global teams in the US and Europe.
- Willingness to collaborate across time zones.
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Required Skills:
Preferred Skills: