Quality Systems Specialist
DEKA Research & Development•Manchester, NH
•Onsite
About The Position
DEKA R&D, on behalf of Millyard Advanced Medical Products, is looking for a Quality Systems Specialist 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.
Requirements
- 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 with documentation in a regulated field such as medical device
- Strong written/verbal communication skills
- Strong computer skills, including Microsoft Office applications (i.e., Word, Excel, PowerPoint) and Adobe Acrobat.
- Ability to learn custom software programs
- Ability to multitask and carry tasks through to completion
- Ability to manage multiple sources of data and develop reports
Nice To Haves
- experience validating eQMS system is preferred
- Prior auditing experience is a plus
Responsibilities
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
