ביוטק

Configuration control

111107

תאריך עדכון

06/06/2019

תיאור המשרה


• Document control specialist is responsible for managing company documents while also ensuring their accuracy, quality and integrity.
In addition, This position conducts engineering and R&D activities and tasks in support of Change control requirements.

Key Responsibilities & Authorities:

• Maintain configuration control in Engineering documents.

• Responsibility on engineering documentation archive.

• Accompanying and executing engineering change processes in the Company's products.

• Providing solutions to documentation problems at manufacturers and contractors.

• Responsibility for tracking information transfer to the ERP and PLM systems.

• Create new templates for DMR documents such as: DHRs, Drawings, Work instructions, Test procedures, Trainings, etc.…

• Responsible for training employees on records management procedures and policies, which include Engineering documentation.

• Support on-going Engineering change control process

• Management of product DMR including BOM, SOP's, Mechanical & electrical specs.

• Configuration management and Implementation of Engineering Changes/ECO.

Education:

• BSc. or practical engineer in Engineering Industrial Engineering & Management is preferred.

• Understanding and knowledge of relevant regulations and standards FDA QSR, ISO 13485, ISO 14971, MDD - Advantage

Experience Requirements:

• At least one year proven experience in documentation control of multi-disciplinary products in Manufacturer Factory.

• Experience with Process Validations and qualification of equipment IQ/OQ/PQ - Advantage

• Experience with ECO process optimization/improvement.
Job Specific Skills (Languages, SW, systems, etc.'):

• Excellent communication skills, both verbal and written in English & Hebrew.

• SolidWorks & Office proficient, experience with PDM/PLM systems, Priority.

• being self-directed and ability to work independently.

• being highly-motivated.

• work in a fast-paced and deadline driven environment.

• multitasking skill is required, and in addition ability to stay focused and carry out their tasks in a timely and accurate manner.

• detail-oriented, dependable and trustworthy.

• quick learner and a team player.

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