NPD 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 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

Quality

Job Sub Function

R&D/Scientific Quality

Job Category

Professional

All Job Posting Locations:

Yokneam, Haifa District, Israel

Job Description

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 NPD Quality Engineer to be in Yokneam.

As a NPD Quality Engineer, you will be responsible for NPI products transfer from development to production, validation activities , supporting activities related to process and production quality improvements, non-conforming products process management

The Quality Engineer Is Mainly Responsible For

• Leading NPI product transfer from development to production

• Manage process validation, including supplier guidance.

• Manage Supplier related activities ( Review and approve supplier nonconformance, Investigations and lead improvement plans with the suppliers)

• Manage activities related to nonconformance methodology (nonconformance follow up and reports, and product dispositions).

• Experience with validations (IQ/OQ/PQ/TMV) and supplier management

• Conduct and support NC investigations (internal and supplier non-conformances).

• Performing analysis of nonconforming products and presenting data in monthly meetings.

• Support the production team in analyzing and reporting the quality event.

• Responsible for Product Development processes in compliance with standards and regulations; implement methodologies and initiate improvements

• Lead design controls of class III devices

• Lead Quality activities during product development

• Leads design changes and assessment

• Review Defect Meetings and Clinical Readiness Results and escalate potential RA/safety issues

Qualifications

• BSc in Engineering/ BA degree or Practical Engineering with Qualification in Quality Assurance (CQE).

• At least 5 years experience in medical systems or medical device companies

• Knowledge of investigations & cause analysis.

• Demonstrated knowledge of manufacturing process principles, practices, and procedures.

• Leading multidisciplinary project and processes

• Good communication skills, both verbal and written in English.

• Good interpersonal relations, reliable and accurate, sense of urgency, and a team player.

Required Skills

Preferred Skills:

Agility Jumps, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Database Backup, Data Savvy, Disruptive Innovations, Issue Escalation, Problem Solving, Process Oriented, Product Improvements, Quality Control (QC), Quality Control Testing, Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Report Writing