Tri Alpha Energy
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Document Control Manager
at Tri Alpha Energy
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.
We have an opening at our Foothill Ranch, CA (Orange County) facility for a Document Control Manager.
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
- 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.