Highlights
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). BASIC QUALIFICATIONS | EDUCATION: BS in Engineering, Chemistry, Bio-Technology, Life Science or related discipline or equivalent combination of education and experience.
Numbers & Facts
| Location | Scarborough, ME |
| Industry | Staffing/Employment Agencies |
| Salary | $25 |
| Company Size | 2,000 to 2,499 employees |
| Year Founded | 2000 |
| Website | http://www.lancesoft.com/ |
Description
Title: Quality Systems Documentation Specialist
Location: Scarborough, ME 04074
Duration: 4+ Months, till year end
RESPONSIBILITIES:
BASIC QUALIFICATIONS | EDUCATION:
PREFERRED QUALIFICATIONS:
Location: Scarborough, ME 04074
Duration: 4+ Months, till year end
- 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 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
About Company
We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.