Implementation of policies and procedures to ensure that Quality. System Regulations (e.g.: FDA Part 820 Quality System Regulation, ISO 13485 Quality Standard) .
Develop, modify, apply and maintain quality procedures, work instructions and protocols.
Conduct investigations and lead corrective/preventive action planning and problem solving efforts.
Conduct material, component, and equipment qualifications
Conduct internal audits.
Provide input to engineering, production, and materials to ensure compliance with procedure, regulations, and standards.
Utilize statistical analysis and recognized quality tools (FMEA, risk analysis, hypothesis testing, and root cause analysis) .
Lead as the QA/Compliance responsible through the different project phases.
Evaluate and approve the qualification documentation, i.e. URS, GxP-Risk Assessment, Validation plan, IQ, OQ, PQ.
Requirements:
Education: A formal Engineering degree in Chemical, Industrial, Mechanical or a B.Sc. in the life Sciences from a known academic institution; A CQE certification and or significant practical experience in the medical device arena are advantageous.
Experience: Minimum three years in the areas of validation and quality engineering in the medical device or pharmaceutical industry.
Languages: Hebrew- speaking, reading, and writing - at a mother tongue level.
English- speaking, reading, and writing - fluent.