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 a Quality Systems Expert role, to join our team located in Yokneam, Israel.
Purpose: We are looking for a Quality Systems Expert to support, maintain, and continuously improve Quality Management System. In this cross-functional role, you will help ensure that quality records, training activities, and core quality processes remain compliant, reliable, accessible, and sustainable.
You will work with stakeholders across the site, provide user support for key quality systems, and contribute to audit readiness and process improvement in a regulated environment.
You will be responsible for:
Support key quality processes and continuous-improvement activities, including CAPA, non-product nonconformances, DRB, QSMR, ICQAs, periodic reviews, and audits.
Support Quality Systems training projects and initiatives, including curricula, user groups, training assignments, and training-plan updates.
Provide day-to-day support to users of the Learning Management System and Agile PLM.
Partner with departments and business units to meet records-retention, legal-hold, and vital-record requirements.
Maintain accurate, complete, protected, and retrievable paper and electronic records throughout their lifecycle.
Coordinate active and inactive record storage, offsite archiving, required metadata, and tracking of archive boxes.
Communicate business issues and improvement opportunities to the appropriate management level.
Follow all applicable company, quality, safety, environmental, and regulatory requirements.
Performs other duties assigned as needed
Qualifications and Requirements:
At least 3 years of experience in a regulated quality environment – mandatory.
Degree in engineering or life science - advantage.
CQE certification – significant advantage
Comfort working with computerized systems and Microsoft Office.
Strong English skills and the ability to review technical documents in English.
Experience with Agile PLM, eTQ, an LMS, or another quality system is an advantage.
Required Skills:
Preferred Skills:
Analytical Reasoning, Business Alignment, Business Behavior, Collaboration, Communication, Compliance Management, Data Compilation, Data Quality, Data Savvy, Document Management, Execution Focus, Quality Auditing, Quality Control (QC), Quality Management Systems (QMS), Quality Services, Quality Standards, Systems Analysis, Training People
