Quality Systems Specialist
Manchester, NH
Full Time
Quality
Entry Level
DEKA R&D has an immediate opening for a Quality Systems Specialist to work in the Quality Department in a dynamic Medical Device Research and Development environment. The position reports to the Quality System Management Team Leader. This is a high visibility role with a significant direct impact in the Quality Management System.
Key responsibilities as a Quality Systems Specialist:
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.
Key responsibilities as a Quality Systems Specialist:
- Operate and maintain document control processes in compliance with established SOPs and regulatory requirements:
- Process and manage Engineering Change Orders (ECOs), Temporary Change Orders (TCOs), and Reprocessing Orders (ROs) through to completion, including red-line changes, impact tracking, training updates for QMS documents, and expedited handling of critical changes to meet project schedules.
- Maintain and utilize Engineering Resource Planning (ERP) and Electronic Quality Management Systems (eQMS) for document control, including modifying/formatting technical documents, facilitating timely reviews and approvals, and performing comprehensive QA document control functions (issuance, distribution, release, and archiving).
- Review and approve quality records to ensure accuracy, completeness, and compliance with regulatory requirements.
- Support continuous improvement initiatives within document control workflows and the broader Quality Management System (QMS).
- Develop a comprehensive understanding of DEKA's products and processes, leveraging this knowledge to enhance QMS effectiveness.
- Support collection, analysis, and trending of QMS data.
- Support internal and external audits.
- Aptitude for Learning: Quickly grasp and apply a variety of processes.
- Effective Communication: Articulate problems and solutions clearly to diverse, cross-functional teams with varying technical backgrounds.
- Project Coordination/Management: Plan, execute, and oversee projects with varying timelines.
- Problem Solving: Tackle challenges with creative, practical solutions.
- Collaboration: Work effectively across teams, share ideas, take initiative, and contribute to common objectives while fostering a positive work environment.
- Attention to Detail: Demonstrate exceptional accuracy and precision in all tasks.
- Reliability: Deliver consistently high-quality work and demonstrate dedication to your role.
- Technical Proficiency: Excel in—or rapidly learn—tools including Excel, Word, and Visio.
- Bachelor’s degree in Science, Engineering, or a related field.
- 1+ years of experience administering processes within a database.
- Strong written and verbal communication skills.
- Advanced proficiency in Microsoft Word, including manipulation of headers/footers, page layout control, document sections, orientation, styles, and tracked changes.
- Strong computer skills with databases and software applications.
- Project coordination and/or project management experience.
- Demonstrated aptitude for learning technical information quickly and accurately.
- 1+ years of experience in a QMS or document-centric environment.
- Experience with document management systems such as Intellect, Veeva, ETQ, and requirements-tracing programs (e.g., DOORS).
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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