Positions address both male and female
Mazor Robotics, Ltd., a Medtronic company
Purpose Statement/General Statement:
· Configuration 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 3 years 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.
Internal: R&D departments, QA/RA, Operations and Product
External: Manufacturer, Suppliers, Sub-Contractors.
Center, Sharon, North