Terumo Aortic requires a Manufacturing Technical Author to work within the Facilities team. The ideal candidate will be responsible for creating and updating documentation to support engineering and facilities PPM’s. Additionally the successful candidate will be responsible for ensuring all documentation complies with all QMS and regulatory requirements.
Key Duties;
1. Provide documentation in form of work instructions, procedures and records to support the transfer of products and processes into TA Glasgow and from TA Glasgow to external critical suppliers
2. Work with Manufacturing Engineers and Quality Engineers across various sites in order to ensure timely duplication of procedures and work instructions into each sites’ respective QMS
3. Develop, initiate, and manage implementation of Change Review Board submissions Engineering Change Orders to enable generated documentation to be implemented
4. Generate relevant required documentation in support of regulatory updates and filings to support Transfer Project implementation, as required
5. Have ability to train associates on defined procedures, as documented
6. Provide assigned task progress updates to Technical Transfer manager and Project Manager
7. Assist project manager in effective management of project progress
8. Have extensive knowledge and experience in MS Excel
9. Have experience in evaluating and amending Risk assessments pertaining to electromechanical equipment.
10. Knowledge of PUWER,PSSR and LOLER
Qualifications & Experience;
11. HND or equivalent
12. Proven relevant technical writer experience in a high-quality manufacturing environment
13. Proven track record in providing high quality documentation for heavily regulated industry would be advantageous
14. Excellent written and verbal communication skills
15. Experience in use of Microsoft Office suite
16. Ability to work on own initiative
17. Ability to work with minimum supervision