Class III 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 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 EngineeringJob Sub Function:
Quality EngineeringJob Category:
Scientific/TechnologyAll Job Posting Locations:
Yokneam, Haifa District, IsraelJob Description:
Position Summary
The Class III Quality Engineer is responsible for supporting the development of Class III medical devices in full compliance with Quality Assurance (QA) standards, regulations, and internal Johnson & Johnson procedures.
The role covers product development activities, risk management, DHF ownership, quality process implementation, audits, and cross‑functional collaboration between HTC and the BWI QA organization.
Key Responsibilities
Product Development Quality (Class III Devices)
- Ensure product development activities comply with relevant standards, regulations, and internal processes.
- Lead and maintain Risk Management activities including xFMEA, risk files, and investigations.
- Review defect meetings, clinical readiness results, and escalate potential regulatory or safety issues.
- Lead design control processes and quality deliverables for Class III devices (NPD and engineering builds).
- Support and lead quality activities during transfer from R&D to manufacturing.
- Assess and approve design changes.
- Maintain and present Quality Plans, metrics, and project status.
- Lead quality investigations and escalate product‑related issues when required.
Tools & Test Equipment Quality
- Lead QA activities for development of tools and jigs.
- Review and approve test equipment qualification and documentation.
Design History File (DHF) Management
- Own DHF management for Class III products.
- Define and approve QA deliverables for R&D projects.
- Conduct credibility checks to ensure documentation accuracy and compliance.
- Ensure HTC development processes align with BWI Quality processes.
- Identify and implement continuous improvements in new product development processes.
QA Compliance
- Act as QA representative for compliance with corporate J&J NPD standards.
- Perform internal product and process audits.
- Support preparation for external audits.
General Responsibilities
- Communicate business‑related issues or opportunities to management.
- Ensure compliance with all applicable regulations, policies, and procedures.
- Perform additional tasks as assigned.
Education & Experience
Required / Preferred Education
- B.Sc. in Engineering (preferred).
- Advantage: Quality Assurance certifications (CQE, CSQE, CQM, CRE).
Experience
- Advantage: Experience in a Quality role, preferably in active medical devices or related industry.
- Advantage: Experience in statistical data analysis methodologies.
Required Knowledge & Skills
- Understanding of ISO and regulatory standards (ISO 13485, ISO 14971, MDD/MDR).
- Strong interpersonal and communication skills.
- Ability to work with remote team leadership.
- Strong English proficiency (spoken and written).
- High integrity, self‑motivation, and ability to work independently or in a team.
- Results‑driven, detail‑oriented, and organized.
#LI-Hybrid #LI-LM5
Required Skills:
Preferred Skills:
Customer Centricity, Data Savvy, Document Management, Execution Focus, Good Automated Manufacturing Practice (GAMP), Issue Escalation, Lean Supply Chain Management, Process Control, Process Improvements, Quality Control (QC), Quality Services, Quality Standards, Quality Systems Documentation, Science, Technology, Engineering, and Math (STEM) Application, Supervision, Supply Planning, Technologically Savvy