Quality Systems Specialist

As a Quality Systems Specialist, you will contribute in the following areas:Champion continuous improvement efforts within the Quality Management System (QMS) teamAttain a comprehensive understanding of DEKA's products and processes, leveraging this knowledge to drive improvements within the QMSCoordinate and drive change control activities, including document revisions, ECO processing, distribution, archival, and training completion trackingExecute and maintain QMS processes to ensure compliance with ISO 13485, FDA QMSR, and internal procedures.Process owner for document control workflows, ensuring documents are controlled, retrievable, and currentSupport CAPA and Internal Audit programs through active involvement in investigations, documentation, tracking of action items, and escalation of overdue actionsPlan and conduct facility inspections and internal audits within defined scope, documenting observations and initiating follow-up actionsReview and approve Quality Records to ensure data integrity and completenessCollect, analyze, and trend QMS data to support reporting into management review and quality metricsMaintain and manage QMS databases and eQMS workflows to support visibility, traceability, and timely execution of quality processesCoordinate external audit logistics, including readiness checks, evidence gathering, and execution supportParticipate in and support QMS improvement initiativesProvide training on QMS processes and promote quality system awareness across the organizationIdentify and escalate potential gaps or nonconformances that could impact compliance or product qualitySupport record filing systems, both manual and electronicAs a key contributor to our team, the following skills are required:Aptitude for Learning: Ability to comprehend and apply learn a variety of processesEffective Communication: Ability to articulate problems and solutions with clarity and precision to a diverse, cross-functional team with varying levels of technical aptitudeProject Coordination/Management: Skilled in planning, executing, and managing projects with varying timelinesProblem Solving: Embrace challenges and find creative solutionsCollaboration: Effectively collaborate with various teams and departments, sharing ideas, taking initiative and proactively contribute to achieve common objectives. Work to maintain a positive attitude, fostering a supportive and productive work environmentAttention to Detail: Display exceptional accuracy and precision in all tasksReliability: Consistently delivering high-quality work and demonstrating dedication to your roleExcellent at utilizing or the ability to quickly learn applications, including Excel, Word, and VisioRequired Training / Knowledge:Preferred experience 2+ years' experience in QMS or document centric environmentBachelor's degree in Engineering or Science degree/background or equivalent1+ years' experience administrating a process within a database2+ years experience in a customer centric environmentStrong written/verbal communication skillsStrong presentation skills (Experience with developing and presenting to management or cross functional teams)Excel, Word, Visio skillsProject coordination/management skillsAptitude for learning technical informationAbout 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.