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) team
• Attain a comprehensive understanding of DEKA's products and processes, leveraging this knowledge to drive improvements within the QMS

• Coordinate and drive change control activities, including document revisions, ECO processing, distribution, archival, and training completion tracking
• Execute 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 current
• Support CAPA and Internal Audit programs through active involvement in investigations, documentation, tracking of action items, and escalation of overdue actions
• Plan and conduct facility inspections and internal audits within defined scope, documenting observations and initiating follow-up actions
• Review and approve Quality Records to ensure data integrity and completeness
• Collect, analyze, and trend QMS data to support reporting into management review and quality metrics
• Maintain and manage QMS databases and eQMS workflows to support visibility, traceability, and timely execution of quality processes
• Coordinate external audit logistics, including readiness checks, evidence gathering, and execution support
• Participate in and support QMS improvement initiatives
• Provide training on QMS processes and promote quality system awareness across the organization
• Identify and escalate potential gaps or nonconformances that could impact compliance or product quality
• Support record filing systems, both manual and electronic

As a key contributor to our team, the following skills are required:

• Aptitude for Learning: Ability to comprehend and apply learn a variety of processes
• Effective Communication: Ability to articulate problems and solutions with clarity and precision to a diverse, cross-functional team with varying levels of technical aptitude
• Project Coordination/Management: Skilled in planning, executing, and managing projects with varying timelines
• Problem Solving: Embrace challenges and find creative solutions
• Collaboration: 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 environment
• Attention to Detail: Display exceptional accuracy and precision in all tasks
• Reliability:  Consistently delivering high-quality work and demonstrating dedication to your role
• Excellent at utilizing or the ability to quickly learn applications, including Excel, Word, and Visio

Required Training / Knowledge:

• Preferred experience 2+ years’ experience in QMS or document centric environment
• Bachelor’s degree in Engineering or Science degree/background or equivalent
• 1+ years’ experience administrating a process within a database
• 2+ years experience in a customer centric environment 
• Strong written/verbal communication skills
• Strong presentation skills (Experience with developing and presenting to management or cross functional teams)
• Excel, Word, Visio skills
• Project coordination/management skills
• Aptitude for learning technical information

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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