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.
leadership to the organization in steering QMS activities including Audit
Management, Management Review, Change Control, Document Control, and Training
- 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
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.
- 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 –
- PLM Experience – Preferred.
- Strong written/verbal communication skills in Hebrew &
- Hands on and independent
- Team player and collaborator.
Please send resume and cover letter to [email protected]