Design QA Team Leader

QA Design Team Lead | Global Medical Device Company

A fast-growing international company, developing and manufacturing innovative medical device solutions, is looking for a QA Design Team Lead to join and lead a professional quality team in a dynamic and advanced environment.

Responsibilities

• :Lead the QA Design team and manage quality activities within R&D processes in compliance with procedures and regulation
• sTake ownership of Design Control, DHF, ECO, CSV, QMS and related quality domain
• sCollaborate closely with R&D, Regulatory Affairs, Engineering, and Manufacturing team
• sSupport product development processes from concept through commercializatio
• nLead and support change processes for existing products and manufacturin
• gManage resources and provide professional guidance to the QA tea
• mLead internal audits and supplier audits בארץ ובחו״
• לAnalyze and present quality KPI
• sParticipate in professional forums and represent management in relevant cross-functional meeting

sRequirements

• :B.Sc. in Biotechnology or Biomedical Engineerin
• g3-5 years of experience in the medical device industry, require
• dAt least 2 years of managerial experienc
• eStrong knowledge of ISO 13485, FDA regulations, and MDR requirement
• sProven ability to lead processes, solve problems, and work independentl
• yFluent English, high leve