Complaints/Quality Support Specialist

DEKA Research & Development • Manchester, NH

6d

About The Position

DEKA is seeking a detail-oriented and motivated Complaints/Quality Support Specialist to join our team. In this position, you will play a key role in maintaining complaint processes and ensuring smooth daily operations within our medical device organization. The ideal candidate will be organized, proactive and comfortable working with documentation and quality systems requirements in a fast-paced environment.

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
Skills we are looking for
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.

Requirements

• Associate’s or Bachelor’s degree in related field (or equivalent 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
• 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.

Responsibilities

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree
• Number of Employees: 101-250 employees