Tri Alpha Energy

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Document Control Manager

at Tri Alpha Energy

Posted: 11/11/2017
Job Status: Full Time
Job Reference #: 103

Job Description

TAE Technologies is leveraging proprietary science and engineering to tackle the world’s biggest challenges. Our core mission is to create a new source of clean energy – one that’s powered by nature’s own processes and produces no harmful byproducts. It’s what we call Friendly Fusion. Our groundbreaking work has effected industry-wide advances in accelerator and plasma physics, and acted as a catalyst for adjacent innovations based on our results. With 20 years of focused research, TAE Technologies is on a purposeful path to commercial fusion energy and pioneering sustainable solutions for a better tomorrow.

 

TAE is in search of a Document Control Manager to join our Team.

 

Essential Duties and Responsibilities:

  • Set up a Document Control Department for a startup medical device company.
  • Implement a part numbering and Engineering Change Request/Engineering Change Order process.
  • Manage documentation and change control functions.
  • Create and assign part numbers for all documents.
  • Proofreading and editing documents for grammatical and spelling accuracy.
  • Analyze Engineering Change Order impact to the Bill of Materials structure and route summary of assessment to affected individuals.
  • Coordinate training for all controlled documents and changes to controlled documents


Required Skills


Required Experience

 

Job Requirements:

  • Experience with Quality Systems standards, including FDA 21 CFR, Part 820 Quality System regulation and ISO 13485.
  • Medical device industry background.
  • Experience with an electronic QMS document control system such as Agile.
  • Proficient in MS Office applications.
  • Certified auditor training preferred.
  • Strong understanding of configuration management.
  • MPR/ERP experience.
  • High level of self-motivation, organization, self-discipline and autonomy
  • Ability to multi-task. 
  • Ability to identify problems and develop and implement solutions to solve them.
  • Experience working in a cross-functional team environment.