Responsibilities:
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 recorded as required.
The Quality Specialist will work both independently, and in some cases closely to project teams, clinical, regulation and R&D.
Responsibilities will include, but are not limited to the following:
● Implementing and maintaining Quality Management System (QMS), that complies with ISO 13485:2016, FDA 21 CFR Part 820, ISO 27001, GDPR, HIPAA and .
● 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.
● Non-conformities and Customer Complaints recording and tracking.
● 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
● Participate and support during company External audits by 3rd party (e.g. CE and FDA)
● Collection and data analysis for reports (i.e. Management Reviews)
Requirements:
● 2-3 years of experience in Quality function in Medical Device company with QMS implementation that complies with FDA 21 CFR Part 820,
ISO 13485, ISO 62304 and ISO 14971 standards;
● Experience in SW as a Medical Device company – advantag
● Familiar with ISO 62304, Medical Device Software – Software Life Cycle processes
● Experience in software Validation and Verification in FDA-compliant medical device industry – advantage
● 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
● Excellent Hebrew and English reading, writing and oral communication skills
● Self-motivated, able to manage priorities
