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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