ABOUT US

Biodesix is a leading diagnostic solutions company with a focus in lung disease. The Company develops diagnostic tests addressing important clinical questions by combining multi-omics through the power of artificial intelligence. Biodesix offers five Medicare-covered tests for patients with lung diseases. The blood based Nodify Lung® nodule risk assessment testing strategy, consisting of the Nodify XL2® and the Nodify CDT® tests, evaluates the risk of malignancy in pulmonary nodules, enabling physicians to better triage patients to the most appropriate course of action. The blood based IQLung™ strategy for lung cancer patients integrates the GeneStrat® targeted ddPCR™ test, the GeneStrat NGS® test and the VeriStrat® test to support treatment decisions across all stages of lung cancer with results in an average of two to three business days, expediting the time to treatment. Biodesix also leverages the proprietary and advanced Diagnostic Cortex® AI (Artificial Intelligence) platform, to collaborate with many of the world’s leading biotechnology and pharmaceutical companies to solve complex diagnostic challenges in lung disease. For more information about Biodesix, please visit www.biodesix.com. 

OVERVIEW

The QMS Analyst is the lead Information and Technology Services (ITS) team member responsible for change control documentation. The ideal candidate is hands-on, willing to learn from others, and has experience providing application support and troubleshooting across an organization. They must possess a friendly and engaging personality and have the capacity to problem-solve and think creatively. This person should embody a passion for continuous improvement and will be responsible for working closely with cross-functional departments to understand needs and create customer experiences that exceed expectations. 

LOCATION
Louisville, CO | Hybrid, 3 Days On-Site

RESPONSIBILITIES

Assist with creating, editing, and maintaining quality management system (QMS) documents (Policies, SOPs, Plans, Protocols, Reports, etc.) to ensure compliance with regulatory and internal quality requirements Ensure change control of software QMS documents, including using approved templates, creating a draft based on ITS team input, initiating cross-functional review, consolidating feedback from multiple contributors, and ensuring approval records are completed Summarize software QMS documentation activities both within the ITS team and for other non-technical audiences such as quality review or audit support Plan, write, and maintain systems and user support documentation, including online help screens Provide clerical and administrative support related to documentation processes and systems Translate business specifications into user documentation and ensure that documentation is accurate and easily accessible Stay current with technology and changing documentation trends, provide recommendations for continuous improvement, and seek supplemental training to improve your performance Work alongside other members of the ITS team to proactively elevate documentation strategy and consistently apply best practices

REQUIREMENTS

Strong analytical skills with the ability to define and identify solutions Excellent written, organizational, communication skills Must work well in a multi-task environment Must be a self-starter, with the ability to establish priorities Excellent customer service skills, including the ability to assist customers in person and remotely over the phone Familiarity with HIPAA and other regulatory requirements listed above, preferred Prior experience with software in a regulated environment, preferred  Exposure to lab or medical business environments and any Lab Information Management System (LIMS), preferred Familiarity with issue tracking software (such as Azure DevOps, Jira or Bugzilla) a plus Ability to work independently and as part of a team Strong attention to detail

EDUCATION AND EXPERIENCE

Associate or bachelor’s degree in Information Systems or IT related subject preferred; H.S. Diploma or GED equivalent with appropriate experience is considered 1 to 3 years of documentation or technical writing experience preferably in an electronic documentation system.

 COMPENSATION

  Hourly Compensation starting at $25.34  Discretionary Bonus opportunity  Comprehensive health coverage: Medical, Dental, and Vision  Insurance: Short/Long Term Disability and Life Insurance  Financial benefits: 401(k), Flex Spending Account  120 hours of annual vacation  72 hours of paid sick time off   11 paid holidays + 3 floating holidays  Employee Assistance Program  Voluntary Benefits  Employee recognition program  ​Individual base compensation is based on various factors unique to each candidate, including skill set, experience, qualifications, and other job-related aspects.    Biodesix is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.