Quality Systems Engineer

Manchester, NH

Full Time

Quality

Mid Level

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

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