Operations Support Specialist

DEKA Research and Development is seeking a detail-oriented and motivated Operations Support Specialist to join our team.  In this position, you will play a key role in maintaining compliant 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 an Operations Support Specialist :

• Assist in daily operational tasks, including inventory management, and logistics coordination Support the development and maintenance of documentation required for medical device distribution Maintain logs, file and maintain QMS records manually and electronically.

Participate in process improvement initiatives to streamline documentation, communication and material flow Provide general administrative support to Operations and Quality Leadership Participate in data analysis activities to track key performance metrics and identify process optimization opportunities Collaborate with cross-functional teams including Quality, Complaints, Operations and Contract Manufacturing to support continuous improvement initiatives Support the coordination of supplier communications and materials 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 Coordinate with Quality and Operations to ensure timely closure of open quality actions Review complaint information to organize partner-specific data Compose, respond, and catalog partner emails related to complaint notification Skills you need to be successful :