Class III Quality Engineer

ientific Quality
Job Category:
Professional
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://https://www.jnj.com/medtech

We are searching for the best talent for a Class III Quality Engineer role, to join our team located in Yokneam, Israel**.**

Purpose: As a Class III 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

You will be 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.

Qualifications and Requirements:

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

• At least 4 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.

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