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We are searching for the best talent for Document Control Specialist I to be in Shockwave Medical Costa Rica.
In compliance with FDA, European MDD/MDR & ISO regulations, the Document Control Specialist I will perform work exercising judgment with supervision. General scope of this position is to maintain product related documentation and the flow of information in the form of controlled documents and engineering change orders, over the life cycle of any given product manufactured at SWMI. This position requires frequent use and general knowledge of industry practices, techniques, and standards.

Essential Job Functions

• Maintain document change control process via engineering change control system (log, track and process DCOs, maintain material and BOM data)
• Check revised documents and completed change orders to assure the highest level of accuracy and conformance with the approved format and standards
• Review, process, and release documents using variety of software packages.
• Ensure documents and records are retained per company procedures.
• Maintain electronic files of master active or archived documents (native source application files as well as the .pdf viewable files)
• Review Quality Records for adherence to Good Documentation Practices (GDPs) and compliance to governing procedures.
• Assist in the data entry setup of training sets for new hires that may include technical and Quality Management System procedures when needed.
• Assist in the data entry of employee training records when needed
• Assist maintenance of Direct Labor Competency Assessment Records when needed
• Other duties as assigned

QUALIFICATIONS

Requirements

• Bachelor’s Degree or advance studies on Engineering or related field, Translation, English or Linguistics.
• At least 1 year of experience working in the medical device industry is preferred.
• Experience in technical documentation in the medical device industry is preferred.
• Working knowledge of MS word, excel and other database systems. Knowledge of Solid Works or other draw programs preferred
• Ability to work in a fast-paced environment while managing multiple priorities
• Must have strong written and verbal skills, and be able to effectively communicate with all levels of the organization
• Operate as a team and/or independently while demonstrating flexibility to changing requirements.
• High attention to detail.
• Self-auditing and have high Quality Standards.
• Employee may be required to lift objects up to 25lbs

Please refer the Job description for details