Quality Assurance Administrator - Documentation Control

Posted 9 Days Ago
Be an Early Applicant
Manchester, NH, USA
In-Office
Junior
Healthtech • Biotech
The Role
The QA Admin manages document control processes, supports QA functions, oversees training documentation, and ensures compliance in a medical device R&D environment.
Summary Generated by Built In
Join our dynamic team at DEKA and be part of creating innovative medical solutions! As our QA Admin focusing on Document Control, you'll play a vital role in supporting the QMS through document control processes in our medical device R&D environment. You'll work collaboratively with cross-functional teams to ensure documentation accuracy and accessibility.
Key responsibilities as a QA Admin (Documentation Control):
  • Perform QA document control functions for processing Engineering Change Orders (ECOs) including issuance, distribution, release, training, and archiving, utilizing DEKAs eQMS
  • Support all administrative functions to the QA and Compliance Manager
  • Process training activities, perform review of training records, and coordinate training database
  • 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
  • Support collection, analysis, and trending of QMS data.
  • Support continuous improvement initiatives within document control workflows and the broader QMS
Skills you will need to be successful in this role:
  • 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
Qualifications:
  • Bachelor’s degree
  • 2+ 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.
  • Local candidates strongly preferred.
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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The Company
HQ: Manchester, NH
670 Employees
Year Founded: 1982

What We Do

DEKA is one of the leading research and development companies in the country and is the birthplace of some of the most innovative and life-changing products of our time. For over thirty years, DEKA Research & Development Corp. has made Manchester, New Hampshire home. Located about an hour from Boston, the beach, and the mountains, we are situated in the beautiful and historic Amoskeag Millyard buildings located in downtown Manchester. DEKA continues to be a place where no idea seems too big and where creativity and crazy cool gizmos reign supreme. The engineers, technicians, machinists, designers and all of the other folks who make up DEKA are some of the most creative and innovative professionals you could ever hope to meet. It's a place where one crazy idea can end up being the next greatest invention. At DEKA we embrace the spirit of innovation and constantly aim to turn the impossible into a reality. DEKA is filled with people who are driven to be among the best and brightest in their field of work. It’s a concentrated bunch of really smart thinkers, doers and problems solvers, who are driven to using innovative design solutions and state-of-the-art technology to improve lives. We all see endless possibilities in the power of technology to do good. Employees have the opportunity to work on diverse projects that have a positive, enduring impact on millions of people worldwide. We are growing! We're always seeking passionate individuals to join our growing team of evolved thinkers.

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