How you will make an impact:
- Review and Approve Quality System Records
- Support updating procedures and processes to support the QMS
- Support the site Corrective and Preventive Action program
- Provide QA support relative to DHR Review/inspections and final acceptance of materials/products
- Review labels for accuracy and precision
- Initiate non-conforming materials reports and segregate / control non-conforming materials as required
- Review and close complaint files per complaint requirements
- 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, CAPA Coordinator, and Calibration Coordinator
- Provide training as required to DEKA personnel
- Promote QMS awareness to non-QA departments throughout DEKA
- Preferred 2+ years’ experience in Quality Assurance in an FDA regulated environment – with QSR (21 CFR Part 820) and ISO 13485 experience if possible.
- 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
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.
Top Skills
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.
