Job Description

Job Description

Job Description

Salary: $25- $35/hr

Job Title: Document Control Specialist

Company Overview

VerAvanti is an innovative medical device company specializing in precision imaging catheters and interventional tools. We plan on becoming the Intravascular eyes for coronary Interventionalists. Our mission is to advance healthcare through cutting-edge technology that enables minimally invasive diagnostics and treatments. We foster a collaborative environment where ones creativity and attention to detail, drive our success in developing life-changing products. VerAvanti is growing to a new Quality Management Software System in preparation for our FDA submission.

Job Summary

We are seeking a QMS Software Administrator for our new QMS Software (still to be chosen) which will be incorporated in the coming weeks. Not only will you be the administrator of this QMS software package, but you will facilitate product owners with their requested documentation changes. This is primarily a desk job, using MS Word, MS Excel, Smartsheets as well as the new QMS Software package. This position is being hired in parallel with the new QMS software package. It is expected that the entire company will receive training of this new software package and this position will receive the most training. There is not an expectation that the applicant be fully versed in the QMS software.

VerAvanti offers opportunities for equity participation, competitive benefits, and professional growth in a dynamic healthcare-focused environment.

Key Responsibilities

• Manage the full lifecycle of documents including creation, identification, review, approval, distribution, revision, and archival to ensure regulatory compliance and data accuracy.
• Maintain master documents such as device master records (DMR), device history records (DHR), design history files (DHF), standard operating procedures (SOPs), and quality manuals.
• Administer the company QMS Software system. Possible Software packages are: IsoTracker, QCBD, SimplerQMS, ZenQMS
• Process and track Engineering Change Orders (RCN/ECO/ECR) to ensure updates to controlled documents are properly reviewed, approved, and implemented.
• Support internal and external audits by generating document history packages and demonstrating compliance with Quality Management System (QMS) requirements.
• Conduct quality control checks for formatting, signatures, and Good Documentation Practices (GDP) before release. This position is not responsible for content ownership or change.
• Coordinate cross-functional reviews with engineering, manufacturing, quality assurance, and regulatory departments to maintain document integrity and change control compliance.
• Train employees on document control procedures and ensure proper use of electronic document systems.
• Archive retired or obsolete documents under regulated retention schedules and ensure accessibility for inspections or recalls

Qualifications and Attributes

• Strong English writing and reviewing skills (Procedural or Technical writing experience preferred).
• Thorough knowledge of MS Word, EXCEL and experience in QMS software usage.
• AA Degree preferred, or other training in technical documentation review (PMP Certification, University-based Certificates, Googles Technical Writing Course)
• Strong attention to detail as you will be reviewing other peoples work for accuracy.
• Ability to work independently.
• Strong communication skills both verbal and written.
• Familiar with working knowledge of document control processes, change management and Good Documentation Practices (GDP)
• Interest in learning ISO and/or FDA regulations and regulatory requirements
• Ability to operate efficiently and effectively in a fast-paced environment

What We Offer

• Competitive market salary commensurate with experience.
• Comprehensive healthcare benefits, including medical, dental, and vision coverage.
• Generous Paid Time Off (PTO) policy to support work-life balance.
• Equity participation opportunities allowing you to share in the company's success.
• Professional development resources, including training and conference attendance.
• A supportive, inclusive workplace with flexible hours and opportunities for advancement.

If you are a driven person with a motor for transforming healthcare through precision work, we encourage you to apply. Please submit your resume and a portfolio of relevant work to Bamboo HR link or visit our careers page. We are an equal opportunity employer.

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