Senior Software Quality Engineer
Title21 Health Solutions – Phoenix, AZ
Title21 Software has positions open for a Software Quality Engineer (SQE) with 3-5 years of experience. The SQE works as a team member in the development and implementation of the Title21 Software platform for organizations in the Health Sciences space including Cellular and Immunotherapy solutions, Document Management, Content Management and eLearning Management solutions. This position is at our Phoenix, AZ office.
Required Skill Set | Technical
- The Quality of the Software.
- The approval of all software and deployment validations.
- Ensuring the product quality through the effective management of the software validation process.
- Ensuring the product quality of the configured solution as part of the software deployment process into the customer environment.
- Direct reports to QA Manager .
- Testing web applications, specifically Windows/IIS based (C#, .NET, ASP.Net MVC, etc,)
- Testing desktop applications
- Ensure that Software Validation deliverables and project milestones are met with multiple projects and deployment teams.
- Providing leadership in furthering the Title21 Culture of Performance through example, mentoring, coaching, training, accountability metrics and reinforcement.
- Providing day-to-day management, coordination, priority-setting of overall business operations for the Software QA Teams and accountable to QA Manager
- Developing, monitoring and ensuring Quality standards exceed customer expectations and supporting QA Manager.
- Fostering a collaborative work environment to achieve employee engagement and arrive at best solutions.
- Gathering, analyzing, interpreting and presenting QA metrics to Senior Management.
- Facilitating and overseeing documentation of QA workflows and practices.
- Overseeing development, maintenance, revisions, adherence and continuous improvement to corporate policies and procedures for the Software QA Team.
- Keeping up-to-date on regulations, relevant technologies, clinical domains and workflows, etc.
- The Software QA Lead is accountable to the QA Manager for the quality of the product software and quality of the software as deployed into the customers environment.
Required Skills and Experience
- Demonstrable and successful experience of at least 10 years (but not to exceed 16 years) in the role of Software QA Lead (or in a similar capacity, such as Senior QA) in managing day-to-day operations of Software QA processes.
- Minimum 3 years’ experience as a Software QA Lead, in an FDA (or similarly regulated) environment such as a Medical device, Pharma or Biotech domains.
- Ability to create validation plans and assemble validation packages.
- Experience in managing direct reports of various levels of QA resources in both automated and manual testing environments.
- Demonstrable experience in each of the above responsibilities and accountabilities.
- Strong analytical and problem-solving skills.
- Strong technical background, with demonstrable and in-depth knowledge of
o Healthcare or Life Sciences Software Systems such as EMR\EHRs, LIMs, QMS, ELNs, LMS, EBRs, etc.
o Software Development Life Cycle using Agile\SCRUM methodologies
o Commercial cloud service infrastructures (e.g. Azure, AWS, etc.)
o Software QA in the context of DevOps.
- A career track showing progressive and increasing responsibilities.
- Strong familiarity with applicable regulations and standards including relevant FDA, CLIA, ICCBBA, AABB, FACT, ISCT, ISO and similar requirements.
- Effective decision-making skills.
- Strong familiarity using common project support toolsets including project management systems, SharePoint, defect tracking, time tracking, etc.
- Excellent verbal and written communication skills.
Desirable Skills and Experience
- Domain expertise and strong familiarity with the requirements and workflows in one or more of the following areas, is highly desirable:
o Standard of Care and IND clinical workflows within BMT Programs (Case Management, BMT Lab, Post Infusion).
o Cell and Gene Therapy Labs protocols\workflows, including experience in protocol development and translational efforts in the support of Phase I and Phase II trials.
o Biologic or Drug manufacturing, especially with regard to processes development and support systems (e.g. Master Batch Record development, Resource Planning, Inventory, etc.).
o Learning Management in clinical or manufacturing environments.
o Quality Management support systems (Document Control, Error Management, etc.)
o Related clinical systems such as LIMS, ELNs, Electronic Batch Records, etc.
- Familiarity and/or experience with software interoperability and instrument integration and operability using HL7 and similar protocols.
- Familiarity with Windows based technology stacks including authentication, remote access/VPNs, TCP/IP, security protocols, etc.
- Familiarity with FormsNet3 and CIBMTR.
- Familiarity and experience using with various aspects of SQL systems (e.g. MS SQL Server, Oracle, MySQL, etc.).
Required Personal Traits
- Highly ethical professional with strong core values.
- A personal and passionate commitment to furthering the fight against cancer.
- Strong, transparent leadership skills.
- Outstanding mentoring capabilities.
- Excellent verbal and written communication skills.
- Positive mindset and open to leaning from failures.
- Highly organized and effective with a great attention to detail.
- Enjoy leading a team of enthusiastic, talented professionals; enjoying a collaborative environment is essential.
- A strong sense of urgency with a bias for action and the ability to be agile in a high growth, fast-paced environment.
- An excellent ability to simplify complex concepts and reconcile competing goals.
- Strong desire and ability to learn and apply new learning, openly state what he/she does not know, learn it and apply it,
- Ambitious and desire to take on more responsibilities in new areas.
- Self-starter, reliable, conscientious, hard-working, customer-focused team member.
- High energy, results-driven, great outlook and perspective, and true grit.
- Candidates will be able to demonstrate a progression of increasing operational responsibilities in organizations that create and deploy software.
Bachelors of Science degree in Computer Science or Computer Engineering from an
accredited four-year university.
Full Time, Non-Exempt. Sponsorship considered for highly qualified applicants.
This position is located in Phoenix, Arizona.
Title21 Health Solutions provides a highly competitive compensation and benefits package including:
- Medical Plan
- Dental/Vision plan
- 401(k) with company match and 100% Immediate Vesting
- Paid Holiday/Vacation/Birthday/Personal days
- Long Term Disability/Life Insurance Plan