Job Description:

We are looking for QMS Manager to join our Quality Assurance full responsibility for products quality in Operation and Process flow, to guarantee that all our products & Process meet quality and Regulatory compliance expectations.
To excel in this role, applicants should demonstrate great attention to details with excellent technical and interpersonal abilities.

Duties and responsibilities:

  • Providing leadership to the organization in steering QMS activities including Audit Management, Management Review, Change Control, Document Control, and Training integration.
  • Lead external inspections and Audits.
  • Defining and maintaining the Quality Management System structure to ensure compliance to Regulations, Policies, including but not limited to, ISO13485, FDA and EU Medical Device Regulations. (MDD/MDR)
  • PMS Activity
  • QA PLAN
  • Internal Audits
  • Maintaining, enforcing, and managing a compliant and effective QMS for the activities in scope, as well as for effective and lean QMS structures and documents for Q&R processes at all levels.
  • Provide Quality support to the company affiliates activities outside of Israel.
  • Ensuring Document Control is established and ensures training profiles are assigned and enforced and training administration is established within scope.
  • Ensuring proper audit planning, preparation, and scheduling meets the requirements of internal policies and external regulations.

Required Qualification:

  • Bachelor’s degree
  • Quality System Manager 2+ Years of relevant experience in Medical Device industries.
  • Previous experience 2+ with Global regulatory requirements in Pharma/Medical industry such as: FDA, EU MDD/MDR, ISO13485 requirements, MDSAP, etc..
  • CQE (Certified Quality Engineer) qualification – Preferred,
  • PLM Experience – Preferred.
  • Strong written/verbal communication skills in Hebrew & English
  • Hands on and independent
  • Team player and collaborator.

Please send resume and cover letter to [email protected]