Shamir Optical is Hiring a HQ Quality Assurance Specialist - JB-73

Responsibility on mapping current QMS status Vs. ISO 13485 (MD - Medical Device) Certification according to group strategy, plan and quality policy. Responsibility on implementing and/or enforcing ISO 13485 (MD Certification) requirements according to the mapping results. • Technical writing and updating of HQ SOPs according to MD regulation and corporate QMS • Admin of QMS Software. such as Document Control app. • Execute tasks related to HQ Quality Projects • Conduct routine Quality trainings (new employees, yearly training to all HQ) • R&D and Engineering technical files Control (review) • Internal documentation review regarding regulatory requirements (such as product markings, labelling/packaging, marketing materials and artworks) • Support risk management processes to products control and critical process changes • Nonconformities management support and follow CAPAs • Post-market surveillance survey • Escorting external audits • Handling customer complaints for R&D products (e.g., Spark4) • Assisting in the process of yearly management review • Keep up to date with changes in MD legislation, guidelines, and standards to support and advise in collaboration with group regulatory compliance manger Report to: HQ Quality Manager & Global Quality Auditor