- Job title Class III QA Team Leader
- Function Quality
- Sub function Quality Assurance
- Category Senior Analyst, Quality Assurance (P6)
- Location Yokneam / Israel
- Date posted
- Requisition number R-045057
- Work pattern Hybrid Work
Description
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:
QualityJob Sub Function:
Quality AssuranceJob Category:
ProfessionalAll 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 Class III QA Team Leader to be in Yokneam.
The Class III QA Team Leader ensures that product development activities comply with Johnson & Johnson quality assurance standards and regulatory requirements throughout the product lifecycle. This role drives quality excellence in new product development (NPD), design controls, risk management, and compliance for Class III medical devices, while fostering collaboration across global teams.
Key Responsibilities
In accordance with all applicable laws, regulations, and Johnson & Johnson procedures, you will:
Product Development Quality Leadership
- Ensure compliance with standards and regulations during product development and implement continuous improvements.
- Lead risk management activities, including xFMEA and problem investigations.
- Oversee design controls for Class III devices and quality activities during NPD and engineering evaluations.
- Manage quality processes during transfer from R&D to production and design changes assessments.
- Maintain quality plans, metrics, and present product status to stakeholders.
- Drive quality investigations and escalate product issues as needed.
Tools and Jigs Development
- Lead quality activities for tools and jigs development, including OOT analysis and approvals.
Design History File (DHF) Management
- Own DHF management for Class III products, ensuring compliance with BWI quality processes and Agile phase approach.
- Define and approve QA deliverables, perform credibility checks, and maintain DHF content.
- Ensure software development processes meet Class III requirements.
QA Compliance
- Act as QA representative for NPD compliance standards.
- Conduct internal audits and support external audit readiness.
- Ensure project teams adhere to relevant standards and processes.
General Responsibilities
- Communicate business-related issues or opportunities to management.
- Ensure compliance with health, safety, and environmental practices.
- Perform additional duties as assigned.
Qualifications
Education:
- Bachelor’s degree in Engineering or related field.
- Preferred: MSc in Quality or Reliability Engineering.
- Advantage: Professional QA certifications (CQE, CSQE, CQM, CRE).
Experience:
- Proven experience as a Quality Engineer, preferably in medical devices.
- Strong background in quality methods for product design.
Knowledge & Skills:
- In-depth knowledge of ISO standards and regulations (ISO 13485, ISO 14971, MDD, MDR).
- Excellent interpersonal and communication skills (English proficiency required).
- Ability to work independently and in global teams.
- Strategic thinker with attention to detail and results-driven mindset.
#LI-Hyberid #LI-LM5
Required Skills:
Preferred Skills:
Business Alignment, Business Savvy, Coaching, Communication, Compliance Management, Continuous Improvement, Fact-Based Decision Making, Human-Centered Design, ISO 9001, Issue Escalation, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP)