Array

Responsible for generating, implementing and monitoring cross-functional quality processes, throughout life cycle of Alma Lasers company, subsidiaries and products
Review, edit and maintain all pre-established QMS policies including training, CAPAs, ECOs and MRBs
Implementation, upgrade and broadening of the company’s SOPs
Manage company’s effective training procedures and processes
Manage company’s daily QA activities
Prepare and manage internal and external audits and certification tasks for CE, ISO 13485, MDSAP, FDA etc.
Work with international bodies such as Notified Bodies and regulatory consultants
Prepare and present management reviews
Manage QA goals to align with company’s long-term strategy and regulatory requirements
Review and approve quality agreements
Lead validation activities related to product release procedures (e.g. sterilization, packaging, transportation)
Proactively involve with Eng/RD with the ability to support to D&D activities
Lead process & production risk management file and cross functional related activities
Supporting product risk management file and cross functional related activities
Prepare QA budget

B.Sc. degree or higher in bio medical, life science, medicine, pharmacy, engineering, or a related discipline
Certification or other evidence of formal qualification in quality management (Advantage)
Knowledge in the field of medical devices with a minimum of eight (8) years of professional experience in QMS (ISO 13485) and regulatory affairs of medical devices, including at least three (3) years in implementing or managing quality systems in active medical devices class IIb or above preferred
Proven experience with CE, FDA, and ROW regulatory compliance
Experience with both Hardware, Software, and single-use components
Advantageous background in managing the transfer from R&D to production and mature products
Excellent reading, writing, and communication skills in English and Hebrew
Strong reporting, teamwork, and time management skills
Ability to learn quickly, analyze problems, work independently, and effectively organize and execute multiple work tasks
Critical thinker, proactive approach, highly motivated and accountable
Internal auditor certified

QA Manager