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Blue Note Therapeutics

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Summary Of Key Responsibilities\n\n\nProvide software quality assurance review, subject matter expertise, and support to product development teams, operations, and information systems in support of corporate production and quality objectives.\n\nServe as Quality core team member on project teams\n\nThis role requires strong communication, interpersonal, and organizational skills and a solid understanding of the application of FDA and ISO 13485 standards.\n\nProvide quality oversight to Software Development and Verification & Validation teams\n\nCreation, review, and approval of quality and project deliverables based on procedural requirements: Design History File Documents, Software Development records, Verification & Validation records, Design Input Documents\n\nEnsure compliance to established process controls (including Design Controls, Risk Management) throughout software lifecycle\n\nCreation, review and approval of quality system and product-related Change Records\n\nDevelop and maintain quality records, procedures, and documents\n\nSupport investigations of NC and CAPA as related to software, product, and QMS issues\n\nProvide support for continuous improvement projects to advance processes and capabilities\n\nWork with key partners to ensure awareness and adherence to policy and procedures\n\nDevelop and deliver training to employees on software validation, software risk management, and general quality tools\n\nMonitor quality metrics, analyze trends, and work with manager to develop action plans\n\nEnsure audit readiness, and represent area as a subject matter expert\n\nProvide Quality management with status updates on assigned responsibilities and goals\n\nManage post market surveillance and product complaint handling\n\nQualifications and Skills\n\n\nExperience working with Corrective Action/Preventive Action, and thinking outside the box in order to ensure Product Development deliverables are created and other aspects of the QMS are defined and executed per the project’s Quality Plan\n\n4+ years Software Quality Engineering or relevant experience\n\nExperience in FDA regulated environment, software as a medical device preferred\n\nExperience with Design Controls and Risk Management for Medical Devices\n\nWorking knowledge of applicable standards and regulations, including 21CFR Part 820, ISO 13485, 14971, FDA’s General Principles of Software Validation, IEC 62304\n\nUnderstanding of Software Development Lifecycle\n\nKnowledge of custom software code development V&V\n\nAbility to read, interpret, and implement regulatory documents, procedures, and reports\n\nPrevious experience developing QMS procedures, Quality Plans, Risk Assessments, CAPA\n\nExperience working in a professional software development environment: formal QA, best practices for schedules, processes, defect identification and resolution, version control, build management\n\nFamiliarity with Waterfall/Hybrid/Agile/SCRUM/etc methodology\n\nAbility to communicate effectively with internal customers, supervisor, team\n\nAbility to effectively compose reports, work instructions, procedures, training\n\nAdaptable to fast-paced, dynamic work environment with shifting demands\n\nThe statements herein describe the general nature and level of work being performed by employees assigned to this position and should not be construed as an exhaustive list of all responsibilities, duties, and skills required or assigned\n\nTRAVEL: Ability to travel up to 30% of the time as needed\n\nCertifications and/or Licensure\n\n\nSoftware certifications (ASQ CSQE) preferred\n\nEducation and/or Experience\n\n\nBachelors degree in Engineering, Computer Science, Sciences\n\nEquivalent combination of experience and/or education may be considered\n\nComputer Skills\n\n\nTo perform this job successfully, an individual should have knowledge of Microsoft software applications, internet capabilities, virtual team applications. Excellent computer skills, including Word, Excel, PowerPoint, gSuite,\n\n\nPhysical Demands/Work Environment\n\n\nWhile performing the duties of this Job, the employee may be regularly required to sit; stand or remain stationary for extended periods of time and use hands and fingers as well as talk and hear. Reasonable accommodations may be made for individuals with disabilities to perform the essential functions.\n\n\nRequirements for Remote Work:\n\n\nA quiet workplace to perform work duties and participate in virtual meetings \n\n\nMust live in a location that can leverage an existing reliable high-speed internet and phone service\n\n\nMinimum upload speed 5 MB/s, preferred upload speed 25 MB/s\n\n\nMinimum download speed 25 MB/s, preferred download speed 50 MB/s\n\n\nCandidates must provide and meet all technical requirements prior to the first day of work

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