Product Complaints Specialist

DEKA Research & Development, on behalf of Millyard Advanced Technologies, is seeking a detail-oriented Complaint Handling Specialist to support our product quality and regulatory compliance efforts. In this role, you will manage complaint documentation and data entry, ensure records meet FDA and QMS requirements, and collaborate with internal teams and external partners to maintain audit-ready documentation in a fast-paced, regulated environment. How you will make an impact as a

Product Complaints Specialist:

Review, document, and enter product complaint information into internal systems with a high degree of accuracy. Request and track additional information needed to complete complaint records and evaluations. Perform complaint data entry and preliminary evaluations while collaborating with team members as needed. Ensure all complaint records follow Good Documentation Practices (GDP), Quality Management System (QMS) requirements, and applicable FDA/regulatory guidelines. Communicate with third-party manufacturers, healthcare professionals, and internal teams to collect and verify complaint details. Maintain organized, complete, and audit-ready documentation within complaint handling systems. Support updates to procedures and work instructions by providing feedback based on day-to-day processes. Maintain professional, clear, and cooperative communication with internal and external contacts. Perform other administrative and support duties as assigned under management supervision. Skills Needed to

Be Successful:

1+ year of experience in a regulated environment (cGMP, healthcare, clinical, or similar) or in a high-volume data entry/administrative role. Basic knowledge of FDA Quality Systems and Medical Device Reporting regulations (21 CFR 803, 820, 211) preferred. Experience with data entry systems or CRMs (e.g., Salesforce) preferred. Strong attention to detail and accuracy in documentation and data entry. Effective time management skills with the ability to prioritize tasks and meet deadlines. Strong organizational and record-keeping skills. Proficient computer skills (Microsoft Office, databases, or similar systems). Clear written and verbal communication skills. Sound technical writing skills. Ability to work independently on routine tasks and collaborate with cross-functional teams when needed. Problem-solving mindset with the ability to follow established procedures and escalate issues appropriately.

About Millyard Advanced Technologies:

https://millyardadvanced.com/ Located in the heart of the Regen Valley in Manchester, NH, our company aims to positively influence the healthcare landscape. Established 2019

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. iORfpQefyl