• 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.
• 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
• 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.