As part of the Akura team, the Document Control Specialist will be responsible for handling paper and virtual document control. Responsible for improvements and enhancements to the enterprise document control system.

Responsibilities, Skills & Hands-On Experience:

• Reviewing for accuracy, and uploading paper records and ensuring that copies are loaded into Akura’s eQMS. This includes Non-conformances, rework, incoming documents, and training records.
• Creating and maintaining eQMS records for equipment. Auditing the records with Operations and R&D. Follow up with equipment owners.
• Adding calibration and preventive measures for equipment and tooling into the database.
• Training and activating eQMS modules such as CAPA, commercial accounts (hospitals that we sell product to), and complaints.
• Maintaining supplier records.
• Contacting suppliers for qualifying documents.
• Format documents for submission. This includes WORD documents that have (1) footnotes (2) referenced tables and figures (3) table of contents, (4) literature citations (5) chapters, and (6) attachments. Generate PDFs of WORD documents.
• Format EXCEL data tables for inclusion into WORD and Format EXCEL graphs for inclusion into WORD.
• Modify PDF files, merge or separate PDF files, and add notes and bookmarks to PDF files.

Education & Work Experience:

• AA or BS not required but desirable.
• Minimum 5 years of relevant experience within the medical device industry.
• Proficient in using Microsoft Office Suite (Word/Excel) and Adobe Acrobat (PDF Editing).