Quality Systems Specialist - Documentation Control

DEKA Research & Development • Manchester, NH

1d

About The Position

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 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.

Requirements

• 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
• Bachelor’s degree in Science, Engineering, or a related field, preferred
• 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.

Responsibilities

• 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
• Coordinate training activities, managing review of training database, oversight of onboarding activities, and providing company-wide support for eQMS training processes
• 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 This Job Offers

• Job Type: Full-time
• Career Level: Mid Level