Quality Systems Specialist - Documentation Control
DEKA Research and Development, Manchester, NH, United States
Quality Systems Specialist - Documentation Control
United States, New Hampshire, Manchester
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.
Key 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
Skills
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 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
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United States, New Hampshire, Manchester
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.
Key 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
Skills
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 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
#J-18808-Ljbffr