MAIN PURPOSE OF JOB:

Responsible for duties related to technical documentation of procedures and practices per quality management system requirements. Ensures proper upkeep of all regulated documents. Controls, maintains, retrieves and distributes documents per company’s document control procedures. Maintains assigned quality system records

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MAIN JOB DUTIES/RESPONSIBILITIES:

·        Work as a Document change analyst and have a technical writing skills

·        Responsible for DCR creation, release and change implementation

·        Review Quality System documentation and update as necessary

·        Responsible for Internal audit and participate in external audit

·        Responsible for Quality records filing and storage

·        Responsible for labeling and marketing document change requests

·        Support documentation training and in process and final product inspection

·        Support History record review and Product release

·        Support Sterilization / Environmental Control activities

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REQUIREMENTS

KNOWLEDGE / EDUCATION

·        Requires a high school diploma or its equivalent. Preferred Bachelor degree

·        Has knowledge of commonly-used concepts, practices, and procedures within related field

·        Knowledge of QSR / ISO13485 / EN 46002 / MDD

JOB EXPERIENCE

·        Requires at least 2 years of experience in the field or in a related area

SKILLS/COMPETENCIES

·        Audit skills

·        Communication

·        Technical writing

·        Has demonstrated organization as well as written and communication skills