Quality Engineer

Required experience (field):

· Preferably experienced in QA in Medical Devices or Pharmaceuticals industry

· In years or range: 2-3 years

Required education:

· Any B.A or B.Sc, preferably Biomedical

· Certified Quality Engineer (CQE)-advantage

· Internal Audit Auditor-advantage

· Fluent and technical English

· GLP Certification

Major missions and responsibilities:

· Lead and control production failures in the company through MRB,

· managing CAPA and Non conformance processes, identification of root cause, determination and

implementation of corrective and preventive actions.

· Lead and control product quality in the company through

· QC checks (include incoming inspection, in process and final release), Improvement Project

· Writing and implementation of company procedures within requirements of FDA (21 CFR 820) and ISO 13485.

· Handling change control processes (ECO).

· Conducting internal quality audits.

· Lead Quality aspects in the biology lab (pre-clinical studies).

· Preparation and analysis of quality data.