How you will make an impact as a Complaints/Quality Support Specialist:
- Provide general administrative support to Complaints and Quality Leadership
- Compose, respond, and catalog supplier emails related to complaint notification
- Ensure that complaint documentation follows Good Documentation Practices; meets QMS requirements; and complies with U.S. Food and Drug Administration (FDA) regulations / ISO requirements.
- Collaborate with cross-functional teams to support continuous improvement initiatives
- Support updating procedures and processes to support the QMS
- Support QMS collection and trending of quality data
- Support vendor qualification and management
- Ensure adherence to FDA 21 CFR Part 820, ISO 13485, and company quality management system requirements
- Assist with audit readiness, CAPA follow-ups, supplier files, or training records as needed
- Education:
- Associate’s or Bachelor’s degree in related field (or equivalent experience)
- Experience:
- 2-5 years of experience in a regulated industry, preferably in medical devices
- Familiarity with ISO 13485, FDA 21 CFR Part 820 or other quality system regulations
- Skills:
- Strong attention to detail and accuracy in documentation
- Proficient with Microsoft Office (Excel, Word, Outlook, Teams, PowerPoint)
- Excellent organizational and multitasking abilities
- Strong communication skills, both written and verbal
- Ability to collaborate cross-functionally
- Ability to work independently and handle multiple tasks in a dynamic environment.
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 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.
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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.
