How you will make an impact:
- 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
- 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 validating eQMS system is preferred
- Experience with documentation in a regulated field such as medical device
- Prior auditing experience is a plus
- 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
- Multitask and carry tasks through to completion
- Manage multiple sources of data and develop reports
https://millyardadvanced.com/
Located in the heart of the Regen Valley in Manchester, NH, our company aims to positively influence the healthcare landscape.
Selected Partners:
- Contract Designer: DEKA Research & Development
- Contract Manufacturer: Merrimack Manufacturing
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 and Development, where we are taking the same innovation and cutting-edge technology into the modern age.
Behind DEKA’s 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.
Skills Required
- 2+ years of experience in a QMS or document-centric environment with an Engineering or Science degree/background, or 5+ years without a degree
- Working knowledge of ISO 13485 and Quality System Regulation
- Proficiency using eQMS systems
- Experience with documentation in a regulated field, such as medical devices
- Strong written and verbal communication skills
- Strong computer skills, including Microsoft Office applications and Adobe Acrobat
- Ability to learn custom software programs, multitask, complete assignments, manage multiple data sources, and develop reports
- Experience validating eQMS systems
- Prior auditing experience
What We Do
DEKA is one of the leading research and development companies in the country and is the birthplace of some of the most innovative and life-changing products of our time. For over thirty years, DEKA Research & Development Corp. has made Manchester, New Hampshire home. Located about an hour from Boston, the beach, and the mountains, we are situated in the beautiful and historic Amoskeag Millyard buildings located in downtown Manchester. DEKA continues to be a place where no idea seems too big and where creativity and crazy cool gizmos reign supreme. The engineers, technicians, machinists, designers and all of the other folks who make up DEKA are some of the most creative and innovative professionals you could ever hope to meet. It's a place where one crazy idea can end up being the next greatest invention. At DEKA we embrace the spirit of innovation and constantly aim to turn the impossible into a reality. DEKA is filled with people who are driven to be among the best and brightest in their field of work. It’s a concentrated bunch of really smart thinkers, doers and problems solvers, who are driven to using innovative design solutions and state-of-the-art technology to improve lives. We all see endless possibilities in the power of technology to do good. Employees have the opportunity to work on diverse projects that have a positive, enduring impact on millions of people worldwide. We are growing! We're always seeking passionate individuals to join our growing team of evolved thinkers.
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