Document Control is responsible for performing administration for the corporate document control process. This includes writing and editing companywide process flowcharts and system documentation that is intuitive and effective in order to achieve and maintain a state of business excellence for Hill-Rom.
•Independently process high volumes of documentation and electronic transactional work following established procedures and work instructions.
•Collaborate with process owners and department personnel to change, improve, and create flowcharts and process documentation such as forms and standard operating procedures based on intuitive design and Good Documentation Practices (GDP). This includes understanding procedures, gathering information, analyzing procedures, addressing issues, resolving problems, and implementing change.
•Consolidate documentation content to minimize/eliminate redundant information.
•Work with global entity personnel to ensure process documentation is consistent from location to location.
•Take concepts & high level direction in order to successfully translate content into appropriate documentation.
•Develop intuitive, coherent & easy to follow documentation that aligns with regulatory requirements.
•Ensure adequate training is conducted and competency is maintained among key process stakeholders.
•Provide remote support for external and internal regulatory inspections as required.
•Minimum of three years of experience in manufacturing operation as quality or manufacturing engineer.
•Excellent verbal and written communication skills, including attention to detail; strong questioning and listening skills; and the ability to look beyond obvious answers in order to understand the impact on other areas is required.
•Ability to read, write, and speak English in a proficient manner.
•Experience in medical device regulations and standards, including FDA medical device regulations covered under Title 21 CFR Part 820, European Medical Device Directive 93/42/EEC is preferred.
|Área||Control de Calidad|
|Horario||7:00 - 17:00 hrs|