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About The Position
- 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
Requirements
- 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
Let’s talk about your future
