Job Description
Join our dynamic team at DEKA and be part of creating innovative medical solutions! As our Quality Documentation Control Specialist, you'll play a vital role in maintaining regulatory compliance through meticulous document control processes in our medical device R&D environment. You'll work collaboratively with cross-functional teams to ensure documentation accuracy and accessibility while supporting our quality management systems.
Key responsibilities as a QA Documentation Specialist: - Process and manage Engineering Change Orders (ECOs), Temporary Change Orders (TCOs), and Reprocessing Orders (ROs) through to completion
- Maintain and utilize Engineering Resource Planning (ERP) database and Electronic Quality Management Systems (eQMS) for effective document control
- Modify and format technical documents according to established SOPs and regulatory requirements
- Facilitate timely document reviews and approvals with project teams and customers
- Expedite critical documentation changes to support project schedules while maintaining compliance
- Support documentation requests during internal and external regulatory audits
- Perform comprehensive QA document control functions including issuance, distribution, release, and archiving
- Provide specialized documentation support for test case review and release processes using custom tools
- Review test records to ensure strict compliance with good documentation practices (GDP)
- Support continuous improvement initiatives related to document control workflows and quality assurance
What we're looking for in a QA Documentation Specialist: - Strong attention to detail: your thoroughness ensures documentation accuracy and compliance
- Excellent organizational skills: you can manage multiple priorities and track numerous documents simultaneously
- Technical proficiency: you have advanced skills in document formatting and Microsoft Office applications
- Effective communication: you can clearly articulate documentation requirements to various stakeholders
- Problem-solving mindset: you identify process inefficiencies and implement improvements
- Adaptability: you thrive in a fast-paced environment with changing priorities
- Independence: you can work with minimal supervision while maintaining high-quality standards
- Collaborative approach: you partner effectively with teams across the organization
To be successful in this role as a Documentation Specialist, you will need the following qualifications: - 1+ year experience in a similar document control or quality assurance role in a regulated industry such as medical device, defense, or similar
- Advanced proficiency in Microsoft Word including manipulation of headers/footers, page control, document sections, orientation, styles, and tracking changes
- Strong computer skills with databases and software packages
- Preferred experience with document management systems such as Intellect, Veeva, ETQ, and requirements tracing programs (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.
Job Tags
Full time, Temporary work,