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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:

+ Associate’s or Bachelor’s degree in Business Administration, Operations Management, Supply Chain or related field (or equivalent experience)

+ 2-5 years of experience in operations, supply chain or administrative support, preferable in medical device or other regulated industries

+ Experience supporting quality, inventory control, purchasing or logistics activities

+ 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 with Operations and Quality Teams

+ Comfortable working with controlled documents, inspection and shipping records

+ Ability to work independently and handle multiple tasks in a dynamic environment

Preferred:

+ Familiarity with ISO 13485, FDA 21 CFR Part 820 or other quality system regulations

+ Experience in document control or quality record maintenance

+ Understanding of basic manufacturing or warehouse processes

+ Knowledge of data entry and reporting within ERP Systems

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.

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