New

Quality Systems Engineer

DEKA Research and Development
United States, New Hampshire, Manchester
340 Commercial Street (Show on map)
May 15, 2025
DEKA R&D has an immediate opening for a Quality Systems Engineer to work in the Quality Department in a dynamic Medical Device Research and Development environment. The position reports to the Quality System Manager. This is a high visibility role with a significant direct impact in the Quality Management System. How you will make an impact: Administer the (electronic) Quality Management System Review and Approve Quality System Records including Complaint records Process changes for QMS Procedures (SOPs) Make red-line changes 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 Act as Lead Training Coordinator and CAPA Coordinator Administer the site calibration program Support the site Corrective and Preventive Action program File records manually and electronically Support QMS collection and trending of quality data Use statistical tools to monitor and report on quality metrics Manage QMS databases for action items and implementation Support vendor qualification and management Support external and internal audits Aid in the development of training programs Provide training as required to company personnel Generate quizzes or other methods to ensure competency following training Skills needed to be successful: Preferred experience 2+ years' experience in QMS or document centric environment with degree in Engineering or Science degree/background or 3+ years' QMS or document centric environment without degree Experience with documentation in a regulated field (medical device preferable) Prior auditing experience is a plus Strong written/verbal communication skills Ability to: Learn custom software programs Multitask and carry tasks through to completion Manage multiple sources of data and develop reports