Associate Specialist Documentation

Title: Quality Systems Documentation Specialist Location: Scarborough, ME - 04074 Duration: Till year end 2026.The position of Quality Systems Documentation Specialist 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 and participating in the development, implementation, documentation, maintenance, and improvement of the business s eQMS.This job description will be reviewed periodically and is subject to change by management. RESPONSIBILITIES:Serve as site-level system administrator of the Change Control module and various other modules in Agile PLMSupport implementation of new modules or new software for the QMSManage system user profiles, user groups and role assignments and troubleshoot user issuesDevelop, prepare, implement, and maintain quality system procedures according to applicable standards and regulationsProcess change orders and requests to standard operating procedures (SOPs) and forms.Monitor the review and approval of documentation managed through the eQMSDevelop and coordinate training programs for new and current eQMS usersRecommend and initiate process improvement initiatives based on identified trends and key performance metricsWork under defined timelines and be accountable for completing work within specified time periodsOther duties as required BASIC QUALIFICATIONS | EDUCATION:BS in Engineering, Chemistry, Bio-Technology, Life Science or related discipline or equivalent combination of education and experienceTwo to five years experience in the medical device industry, preferably in Quality or Document/Change ControlDemonstrated proficiency using Microsoft Office applications PREFERRED QUALIFICATIONSFamiliar with federal and other regulations, e.g. QSRs, ISO 13485, CMDR, IVDD/IVDR. Working knowledge of the General Provisions of 21 CFR Part 11 for Electronic Records and Electronic Signatures preferred.Advanced proficiency in the use of computerized systems to effectively administer the specialized eQMS applications, as well as efficiently utilize common office applications (Microsoft Office, Adobe). A working knowledge of Agile PLM or equivalent is preferred.Strong analytical, verbal communication and writing skillsAbility to work in a team environment as well as independently and with minimal supervisionAbility to communicate in writing clearly and concisely, using grammatically correct sentence structureExperience in the manufacture and development of product, preferably medical devicesExperience with and understanding of medical device quality systemsSkilled in tasks associated with document handling, archiving and change managementStrong attention to detail and accuracyStrong time management, organizational, and prioritization skillsAbility to effectively manage multiple projects and prioritiesAbility to interface professionally at all levels of the organization