Quality Systems Specialist
Quality Systems Specialist
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
How you will make an impact:
- Review and Approve Quality System Records
- Process changes for QMS Procedures (SOPs)
- Make red-line changes
- Process ECOs 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
- Support the site Corrective and Preventive Action program
- File and maintain records manually and electronically
- Support QMS collection and trending of quality data
- Manage QMS databases for action items and implementation
- Support vendor qualification and management
- Support external and internal audits
- Support as backup to Training Coordinator and CAPA Coordinator
- Provide training as required to DEKA personnel
- Promote QMS awareness to non-QA departments throughout DEKA
- 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 such as medical device
- 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
About DEKA:
One hour from the beach Boston and the mountains the historic Amoskeag Millyard once housed the largest textile mills in the world. It is now home to DEKA Research & Development where we are taking the same innovation and cutting-edge technology into the modern age.
Behind DEKAs brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering design and manufacturing. Here at DEKA some of the most innovative and life-changing products of our time are created and new ideas are always welcome and explored.
Required Experience:
Manager
Employment Type
Full-Time
