Jobs

Description

Start Time (AM/PM)   8:00am 
End Time (AM/PM)   5:00pm

The position of Quality Systems Documentation Specialist within our  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 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

BASIC QUALIFICATIONS | EDUCATION:

• 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

PREFERRED QUALIFICATIONS:

• Familiar 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 skills
• Ability to work in a team environment as well as independently and with minimal supervision
• Ability to communicate in writing clearly and concisely, using grammatically correct sentence structure
• Experience in the manufacture and development of product, preferably medical devices
• Experience with and understanding of medical device quality systems
• Skilled in tasks associated with document handling, archiving and change management
• Strong attention to detail and accuracy
• Strong time management, organizational, and prioritization skills
• Ability to effectively manage multiple projects and priorities
• Ability to interface professionally at all levels of the organization