Inbal Dror Email & Phone Number

Israel

Israel

Responsible for various quality system processes - CAPAs, QSMR - Quality System Management Reviews, DRB - Defect Review Board, ICQA - Intra Company Agreement, Special releases, Training etc.Verify all processes are followed, maintained stand with medical device quality requirements.

Yokneam, Northern, Israel

Establishing regulatory strategies. Define, review and maintain quality activities in projects during all development phases;Responsible for harmonized standards implementation - review changes under updated standards, working with internal team to verify impact on site processes/ deliverables, identify gaps and required activities, including monitoring gaps closure;Update local and global procedures as part of Quality Simplifications and harmonized product development processes… Show more Establishing regulatory strategies. Define, review and maintain quality activities in projects during all development phases;Responsible for harmonized standards implementation - review changes under updated standards, working with internal team to verify impact on site processes/ deliverables, identify gaps and required activities, including monitoring gaps closure;Update local and global procedures as part of Quality Simplifications and harmonized product development processes. Professional and managerial guidance of team members Show less

- Creating and updating work instructions and templates;- Work with Global and local teams to assess, understand and implement new EU regulatory requirements (MDR)- Partner in setting development strategies, job outlines and deliverables in site products (NPIs)- Certified lead auditor – Conduct Internal audits to Haifa and other GE sites- Preparation to internal and external audits (Gmed and TUV as notified bodies); leading audits as well as support External audits in other GE… Show more - Creating and updating work instructions and templates;- Work with Global and local teams to assess, understand and implement new EU regulatory requirements (MDR)- Partner in setting development strategies, job outlines and deliverables in site products (NPIs)- Certified lead auditor – Conduct Internal audits to Haifa and other GE sites- Preparation to internal and external audits (Gmed and TUV as notified bodies); leading audits as well as support External audits in other GE sites- Training of new team members Show less