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Quality Systems Specialist - Documentation Control

DEKA Research & Development · Manchester, New Hampshire, US

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...

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 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 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 - 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 int...