Document Control Specialist
Skills
About This Role
Overview
Akura Medical, a Shifamed portfolio company, is advancing a differentiated platform for the treatment of venous thromboembolism (VTE), which affects up to 900,000 Americans each year.
The company recently received US IDE approval for its QUADRA-PE study evaluating the Katana™ Thrombectomy System in acute pulmonary embolism patients.
In parallel, Akura Medical is developing NavIQ™, a software platform that transforms CT angiograms into 3D pulmonary vascular models to enhance visualization, procedural planning, and clot assessment towards better safety, efficacy, and ease of use.
Akura has recently completed a $53 million first close of its Series C financing, led by the Qatar Investment Authority, supporting the launch of a joint venture and a new R&D and manufacturing center in Doha, Qatar.
About Shifamed
Founded in 2009 by serial entrepreneur Amr Salahieh, Shifamed LLC is a privately held medical device innovation hub focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology.
Description
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.
, 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, 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), 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 content (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.
& 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).
- Our salary ranges are calculated by role, level, and location.
- Please note that your position within that range will be determined by your job-related knowledge, location, skills, experience, relevant education, and training/certifications.
- NOTICE TO CANDIDATES: Please be aware that Shifamed and its portfolio companies do not conduct interviews or extend offers through mobile web chat applications.
- Please report any such occurrences to hr@shifamed.com.
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