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DR
DEKA Research & Development
Quality Systems Specialist
Career Insights for Systems Administrator
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Based on New Hampshire data
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What they do
A Systems Administrator manages the day-to-day operations of an organization's computer networks, including the systems that connect computers and other technology to each other and to outside networks. Installs, organizes, and supports the hardware and software of these systems.
$99,393 / year median in New Hampshire
-28% projected decline
Job Description
DEKA R D, on behalf of Millyard Advanced Medical Products, is looking for a Quality Systems Specialis t to work in a dynamic Medical Device Research and Development environment. The position reports to the Director of Quality. This is a high visibility role with a significant direct impact in the Quality Management System. How you will make an impact: Responsible for documents, records, DCN, and Training processes Review and Approve Quality System Records Works closely with the Quality Systems Manager to implement an eQMS system Create, implement, and maintain existing quality system documentation and manage changes to process/product documents, including format and numbering, record retention, change control and document distribution Ensure document accuracy, quality, and integrity Process changes for QMS Procedures (SOPs) Make red-line changes Process DCNs to approval signatories Make new master documents, archive and distribute via electronic system Track training for QMS documents within the Change Order process Track open impacts to completion Support updating procedures and processes to support the QMS File and maintain records manually and electronically Establish, monitor, and respond to metrics on the efficiency of the document management and training processes and its ability to support the business Manage QMS databases for action items and implementation Support external and internal audits Provide training as required to DEKA personnel Promote QMS awareness to non-QA departments throughout DEKA Skills needed to be successful: 2+ years' experience in QMS or document centric environment with degree in Engineering or Science degree/background or 5+ years' QMS or document centric environment without degree Understanding and working knowledge of ISO 13485 and Quality System regulation is required Proficient in the use of eQMS systems; experience validating eQMS system is preferred Experience with documentation in a regulated field such as medical device Prior auditing experience is a plus Strong written/verbal communication skills Strong computer skills, including Microsoft Office applications (i.e., Word, Excel, PowerPoint) and Adobe Acrobat.