Validation Engineer

Sinai Medical – a leading medical engineering company providing R&D and NPI/production engineering services to companies in the medical devices field, is looking for a Validation Engineer. The position is located at our client’s site in Caesarea.

Job Description:

The Validation Engineer will implement the company validation strategy, based on the company procedures and regulatory requirements. The engineer will authorize validation documentation to ensure compliance with regulations and validation best practices and executing and managing validation activities. Also, will support validation activities by providing guidance and expertise to authors of validation documentation and executors of validation protocols.

Responsibilities:

· Run process qualifications including Instillation Qualification, Operational Qualification and Performance / IQ OQ PQ.

· Develop, design and execute validation protocols.

· Representing validation at both internal and external audits.

· Write, review and approve engineering change control, plant validation protocols and reports.

· Coordinate and act as subject matter expert for the site’s Master Validation Plan, schedule, execution of schedule, validation police and practice.

· Having knowledge of and ability to provide Interpretation and Guidance on Regulations, and Site Local procedures as they relate to validation activities.

Required Qualifications:

· Bachelor's degree in an engineering and/or scientific orientation field.

· Working experience of at least 2 years in the field of Medical Devices.

· Aware of and comply with medical device Quality Management System.

· A good understanding of statistical techniques, in particular statistical sampling plans, Process Capability, Gauge R&Rs.

· Knowledge and understanding of document control, design transfer, verification, validation, acceptance activity, DMR, DHR.

· Proficient in English and Hebrew

· self-motivated, Independent in leading Projects and tasks, Good verbal and written communication skills – must have