Blue Note Therapeutics is a prescription digital therapeutics company singularly dedicated to transforming mental health care for cancer patients. We aim to make mental health care available to any cancer patient at any time by merging deep scientific and clinical expertise, neuroscience, and digital innovation.
We have an immediate need for a Software Quality Assurance Engineer to support integration of Product Development with the Quality Management System. This position will partner closely with development teams to ensure that relevant QMS processes are understood, implemented, and functioning as intended, as well as identifying areas for improvement. With an emphasis on supporting quality throughout the product development lifecycle, this position differs from a testing role, however knowledge of development and execution of test scripts is a plus.
Summary Of Key Responsibilities
- Provide 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.
- Serve as Quality core team member on project teams
- This role requires strong communication, interpersonal, and organizational skills and a solid understanding of the application of FDA and ISO 13485 standards.
- Provide quality oversight to Software Development and Verification & Validation teams
- Creation, 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
- Ensure compliance to established process controls (including Design Controls, Risk Management) throughout software lifecycle
- Creation, review and approval of quality system and product-related Change Records
- Develop and maintain quality records, procedures, and documents
- Support investigations of NC and CAPA as related to software, product, and QMS issues
- Provide support for continuous improvement projects to advance processes and capabilities
- Work with key partners to ensure awareness and adherence to policy and procedures
- Develop and deliver training to employees on software validation, software risk management, and general quality tools
- Monitor quality metrics, analyze trends, and work with manager to develop action plans
- Ensure audit readiness, and represent area as a subject matter expert
- Provide Quality management with status updates on assigned responsibilities and goals
- Manage post market surveillance and product complaint handling
Qualifications and Skills
- Experience 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
- 4+ years Software Quality Engineering or relevant experience
- Experience in FDA regulated environment, software as a medical device preferred
- Experience with Design Controls and Risk Management for Medical Devices
- Working knowledge of applicable standards and regulations, including 21CFR Part 820, ISO 13485, 14971, FDA’s General Principles of Software Validation, IEC 62304
- Understanding of Software Development Lifecycle
- Knowledge of custom software code development V&V
- Ability to read, interpret, and implement regulatory documents, procedures, and reports
- Previous experience developing QMS procedures, Quality Plans, Risk Assessments, CAPA
- Experience working in a professional software development environment: formal QA, best practices for schedules, processes, defect identification and resolution, version control, build management
- Familiarity with Waterfall/Hybrid/Agile/SCRUM/etc methodology
- Ability to communicate effectively with internal customers, supervisor, team
- Ability to effectively compose reports, work instructions, procedures, training
- Adaptable to fast-paced, dynamic work environment with shifting demands
- The 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
- TRAVEL: Ability to travel up to 30% of the time as needed
Certifications and/or Licensure
- Software certifications (ASQ CSQE) preferred
Education and/or Experience
- Bachelors degree in Engineering, Computer Science, Sciences
- Equivalent combination of experience and/or education may be considered
To 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,
Physical Demands/Work Environment
While 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.
Requirements for Remote Work:
A quiet workplace to perform work duties and participate in virtual meetings
Must live in a location that can leverage an existing reliable high-speed internet and phone service
Minimum upload speed 5 MB/s, preferred upload speed 25 MB/s
Minimum download speed 25 MB/s, preferred download speed 50 MB/s
Candidates must provide and meet all technical requirements prior to the first day of work
We are Blue Note Therapeutics
Blue Note Therapeutics is a prescription digital therapeutics company singularly dedicated to transforming mental health care for cancer patients. We aim to make mental health care available to any cancer patient at any time by merging deep scientific and clinical expertise, neuroscience, and digital innovation. Working closely with leading cancer centers, community oncology clinics, and teams of patients, Blue Note is developing clinically validated prescription digital therapeutics to help reduce anxiety, depression and other distress related to cancer.
Click here to apply for this opportunity Quality Assurance Engineer.