Quality Management Analyst

Direct message the job poster from Biodesix, Inc.Talent Acquisition Partner - Biodesix | Corporate RecruitmentABOUT USBiodesix is a leading diagnostic solutions company, driven to improve clinical care and outcomes for patients. Biodesix Diagnostic Tests support clinical decisions to expedite personalized care and improve outcomes for patients with lung disease. Biodesix Development Services enable the world’s leading biopharmaceutical, life sciences, and research institutions with scientific, technological, and operational capabilities that fuel the development of diagnostic tests, tools, and therapeutics.Our Mission: Transform patient care and improve outcomes through personalized diagnostics that are timely, accessible, and address immediate clinical needs.Our Vision: A world where patient diseases are conquered with the guidance of personalized diagnostics.For more information, please visit Quality Management System (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.LocationLocation details are not specified in this description.ResponsibilitiesAssist with creating, editing, and maintaining quality management system (QMS) documents (Policies, SOPs, Plans, Protocols, Reports, etc.) to ensure compliance with regulatory and internal quality requirementsEnsure 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 completedSummarize software QMS documentation activities both within the ITS team and for other non-technical audiences such as quality review or audit supportPlan, write, and maintain user support documentation, including online help screensProvide clerical and administrative support related to documentation processes and systemsTranslate business specifications into user documentation and ensure that documentation is accurate and easily accessibleStay current with technology and changing documentation trends, provide recommendations for continuous improvement, and seek supplemental training to improve your performanceWork alongside other members of the ITS team to proactively elevate documentation strategy and consistently apply best practicesRequirementsStrong analytical skills with the ability to define and identify solutionsMust work well in a multi-task environmentMust be a self-starter, with the ability to establish prioritiesExcellent customer service skills, including the ability to assist customers in person and remotely over the phoneFamiliarity with HIPAA and other regulatory requirements listed above, preferredPrior experience with software in a regulated environment, preferredExposure to lab or medical business environments and any Lab Information Management System (LIMS), preferredFamiliarity with issue tracking software (such as Azure DevOps, Jira or Bugzilla), a plusAbility to work independently and as part of a teamStrong attention to detailEducation and ExperienceAssociate or bachelor’s degree in Information Systems or IT related subject preferred; H.S. Diploma or GED equivalent with appropriate experience is consideredAt least 1 year of technical writing experience, required.2+ years of Electronic documentation system / Quality Management System experience, preferred.1+ years of software development lifecycle (SDLC) experience, pensationAnnual Compensation Range $52,700 to $60,200Discretionary Bonus opportunityComprehensive health coverage: Medical, Dental, and VisionInsurance: Short/Long Term Disability and Life Insurance120 hours of annual vacation72 hours of paid sick time off11 paid holidays + 3 floating holidaysEmployee Assistance ProgramVoluntary BenefitsEmployee recognition programBiodesix 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.Get notified about new Quality Analyst jobs in Louisville, CO. #J-18808-Ljbffr

Created: 2025-10-05