Quality Systems Documentation Specialist
About the role
The position of Quality Systems Documentation Specialist is within our Infectious Disease business unit located at Scarborough, Maine. In this role you will perform daily activities required to maintain the electronic Quality Management System (eQMS). This position is also responsible for participating in the development, implementation, documentation, maintenance, and improvement of the business’s eQMS.
Responsibilities
- Serve as site-level system administrator of the Change Control module and various other modules in Agile PLM
- Support implementation of new modules or new software for the QMS
- Manage system user profiles, user groups and role assignments and troubleshoot user issues
- Develop, prepare, implement, and maintain quality system procedures according to applicable standards and regulations
- Process change orders and requests to standard operating procedures (SOPs) and forms
- Monitor the review and approval of documentation managed through the eQMS
- Develop and coordinate training programs for new and current eQMS users
- Recommend and initiate process improvement initiatives based on identified trends and key performance metrics
- Work under defined timelines and be accountable for completing work within specified time periods
- Other duties as required
Qualifications
BASIC QUALIFICATIONS: BS in Engineering, Chemistry, Bio-Technology, Life Science or related discipline or equivalent combination of education and experience. Two to five years’ experience in the medical device industry, preferably in Quality or Document/Change Control. Demonstrated proficiency using Microsoft Office applications.
Pay
Pay ranges between $22-27/hr based on experience