We're looking to hire a Full Time Sr. Software Test Engineer to work for a very stable and rapidly growing Life Sciences company in San Diego.Title:
Sr. Software Test EngineerLocation:
San Diego, CACompany
They are committed to improving lives through the development and commercialization of novel pharmaceutical, nutritional and diagnostic products that enable physicians to provide greater individualized patient care. One of the biggest initiatives that the QA and Dev teams are working towards is the release of their Lab Development Test kit that is used by doctors for patient test results, which will be marketed and sold on an international scale. Beyond that, there are a multitude of projects and systems (including their LIMS Lab Information Management System) that require heavy testing and validation, for which this position with play an instrumental role.
The team is currently comprised of the QA Manager, QA Lead, one Sr. Test Engineer and one more Test Engineer. They collaborate heavily with the development team, with which they have a very positive working relationship.Requirements:5+ years within QA (strong knowledge of SDLC and end-to-end testing with test plans, test cases and other test documents)Must have SQL skills (ability to write queries for data mining and create joins)Ideally experienced within an FDA / ISO regulated environment performing validation and verification(preferred)Other Skills/Experience
- Software validation process experience, specifically within FDA and ISO regulated environments (must have strong documentation and writing skills)
- Familiar with UML.
- Familiar with test automation (this role is primarily manual, but they have CodedUI in the environment and they plan to eventually expand on more automation)
- Strong knowledge of Microsoft Office products (Word, Excel, PowerPoint, Project, Visio).
- Familiarity with HL7, XML is a plus.
- Soft skills (team player, presentation skills, firm with the ability to push back when necessary)
- Bachelor Degree required (ideally within Computer Science or related field)
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- Perform Risk Assessment and document the results.
- Write and execute all required documents for Verification and Validation of software systems.
- Perform Software validation to ensure compliance with FDA (21 CFR Part 11, 820) and ISO standards.
- Perform integration testing with LIMS and laboratory equipment.
- Perform manual blackbox, white box, and some automation testing.
- Verify test results using Microsoft SQL.
- Write reports summarizing test results, defect results and present findings during User Acceptance Testing to end user clients.
- Assist software developers and domain experts in designing, performing, and improving verification tests.
- Work with scientists, technicians, engineers, and project management to develop new SW or sustain validated SW.
- Formalize, standardize and document QA processes, procedures and guidelines.
- Interact with cross-disciplinary project teams in order to meet project milestones and end goals.
- Other duties as assigned.
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