We are growing and are looking for a Verification & Validation Specialist to join us!
You will:
Work with the Engineering and Mobile Development teams to review software requirements in establishing the appropriate test cases in testing protocols.
Review and contribute to risks evaluations, establishing software requirements, and technical documentation developed during the Software Development Lifecycle and in servicing activities.
Create and execute new verification and validation (V&V) plans.
Write software testing protocols that will be executed as part of V&V.
Write software test reports (STRs) and log evidence of testing activities
Identify software problems, evaluate the risk associated with software problems, and work with the engineering team to handle software defects identified during software testing.
Summarize and document the results of V&V testing with respect to the defined software/user requirements and risk.
Update traceability documents to ensure coverage of risks, software requirements, and design elements in software testing protocols.
Review existing testing protocols to ensure that test cases and steps are sufficient and properly test evolving requirements.
Write and maintain automation tests for mobile and server side.
Work with the Software Development Lifecycle Manager and Product Manager to coordinate the timing and delivery of software test results in accordance with defined project milestones and deadlines.
Requirements:
Minimum 3 years in a software testing role (quality assurance, verification, validation, or similar) for software incorporated in a medical device or software as a medical device (SaMD); experience with SaMD strongly preferred.
Experience with mobile testing (Android and iOS).
Proven experience in mobile/server-side testing automation preferred.
Well organized and responsible person who can deliver under tight timelines.
Fluent in speaking, writing, and reading English.
Working knowledge of the Design Control Regulations in 21 C.F.R. 820.30, additional expertise in the Quality System Regulation (21 C.F.R. 820) and other medical device regulations in the USA preferred.
Understanding and experience working with an ISO 13485:2016 preferred.
Demonstrated understanding of IEC 62304; understanding and use of IEC 82304 a plus.
Experience working in AGILE development environment.
Experience using an eQMS for document control and management; experience with MasterControl a plus.