Tri Alpha Energy
Receive alerts when this company posts new jobs.
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.
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
- 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.