Zebra has set out on a mission to help hundreds of millions of people receive access to fast, accurate medical diagnosis through the design and development of medical devices of only the highest quality. We are looking for a Quality Assurance Specialist to join our team and turn this mission into a reality.
The QA Specialist will be responsible for monitoring, coordinating and maintaining the company’s quality management system and processes in order to meet established quality standards and release top of the line products.
Responsible for quality assurance activities, developing and maintaining QA policies, monitoring and tracking internal processes and providing support for the development and implementation of continuous improvement activities throughout the organization.
Ensures Quality system performance is measured and routinely reported to executive management.
The QA Specialist will work both independently, and in some cases closely to project teams, clinical, regulation and R&D.
- Implementing and maintaining Quality Management System (QMS), that complies with ISO 13485:2016, ISO 27001, GDPR, HIPAA and FDA 21 CFR Part 820.
- Develop, administer and maintain quality assurance procedures and activities required to ensure that the company’s processes and products are in compliance with applicable quality standards and requirements. Continuous improvement of Quality assurance processes and procedures.
- Failures and root cause analysis, corrective and preventive actions to respond to non-conformities and customer complaints.
- Interface with Regulations, R&D, Operations and Product Management to implement appropriate verification activities and documentation supporting release of products
- Support the quality inspections to ensure projects, products and processes comply with the relevant requirements of the QMS
- Coordinate Company Training and implementation as required by the Quality management system
- Support in company External audits by 3rd party (i.e. CE and FDA)
- Collection and data analysis for reports (i.e. Management Reviews)
- At least 3 years of experience in Quality function in Medical Device company;
- Experience in SW as a Medical Device company - advantage.
- Familiar with ISO 62304, Medical Device Software – Software Life Cycle processes
- Experience in software Validation and Verification in FDA-compliant medical device industry - advantage
- 3+ years of experience with QMS implementation that complies with FDA 21 CFR Part 820, ISO 13485, ISO 62304 and ISO 14971 standards
- Knowledge of FDA Quality System requirements, ISO 13485:2016 (Quality System) requirements, ISO 27001, 14971 (Risk Management) requirements, Medical Device Regulation (MDR) requirements, Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards
- Familiar with new European Medical Device Regulation (MDR)- advantage
- BS/BA in engineering or science discipline
- Detail oriented, demonstrated success in a start-up, entrepreneurial work environment
- Good communication skills, both verbal and written
- Excellent Hebrew and English reading, writing and oral communication skills