Quality Systems Engineer
Quality Systems Engineer
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
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 redline 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
- 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
Required Experience:
Manager
Employment Type
Full-Time
