25 Feb
QA Device Testing
Delaware, Newark , 19702 Newark USA

Vacancy expired!

Position: QA Device Testing

Location: Newark, DE

Duration: 6+ months

Rate: Open

Interview: Video

Job Summary: The Verification and Validation (V&V) Specialist will be engaged in verifying custom designed, software-driven production test equipment deployed into manufacturing sites to assess the performance of electro-mechanical assemblies. V&V Specialists will also verify the functional correctness of production support software systems. All V&V activities are to be conducted according to FDA requirements and internal quality standards. This position provides support to the New Product Development Technical Operations team to meet project deliverables in the completion of development testing. Project deliverables include producing verification and/or validation plans, protocols, and reports; execution of the plans and protocols; and resolving deviations. The V&V specialist ensures V&V procedures are aligned to internal and regulatory process requirements.

Job Duties:
  • Prepare validation and performance qualification protocols for new and/or modified processes, systems or equipment.
  • Author/review and approve technical deliverables such as functional specification, verification plan, user requirement specification, functional requirement specification, design specification, test method validation, installation qualification protocol and summary report, operational qualification protocol and summary report, performance qualification protocol and summary report, test plan, test scripts which interact with Siemens proprietary Global Testing Platform
  • Assist in design and development of complex test systems, contribute to system analysis, the definition of user requirements and assesses impacts. Determine alternate solutions with risk analysis and identify opportunities to use technology to improve availability and advance business initiatives
  • Ensure system compliance with Good Manufacturing Practice, Current Good Laboratory Practice, Current Good Documentation Practices, and FDA regulations such as 21 CFR Part 11 and Part 820
  • Work with users and project engineers to define system needs and represent user needs, translating user requirements to logic diagrams and program statements for the purposes of test and validation.
  • Develop OQ test cases and provide input towards IQ, PQ protocols
  • Execute IQ and OQ protocols
  • Perform Test Method Validation to finalize the testing methods.
  • Author technical documents (protocols, reports, standard operating procedures) to comply with regulatory requirements, Siemens quality procedures, and group functional needs
  • Review and test diagnostics mechanisms for newly developed testers
  • Provide technical support for systems. Plan and coordinate tests for assigned project, identify opportunities to improve tester designs and test methods.
  • Assist in the development, design/code, debug and implementation of electro-mechanical systems using LabVIEW architecture to test the instrument sub-systems.
  • Provide technical analysis and solutions to issues and technical direction.
  • Schedule and prioritize assigned work activities that accomplish the planned targets. Set priorities and provide progress reports to the management.
  • Author and manage test cases and bug through life cycle using Microsoft TFS and MTM software applications.
  • Works closely with all engineering disciplines including R&D Systems Engineering, Project Management, and Quality personnel to verify and validate products
  • Work with project teams to create, review, and approve verification and validation deliverables
  • Review and analyze test data and record pass/fail results
  • Troubleshoot and perform root cause analysis for tester hardware and software defects
  • Work with electro-mechanical systems
  • Summarize the verification and validation performed, the data reviewed, and conclusions reached
  • Review test input requirements for completeness, correctness, clarity and testability
  • Conduct Test Method Validation, Gauge Repeatability and Reproducibility studies, Failure Mode and Effective Analysis, Software Hazard Analysis and ensure Risk Control Measures are implemented in design for system under development.
  • Identify and conduct training for V&V team members

Education/Experience Requirements:
  • B.S. degree in Computer Science, Engineering or other related discipline
  • 3+ years of experience in design verification or validation, emphasis on software driven hardware testing
  • IQ, OQ, PQ process experience
  • Experience creating verification and validation plans, protocols, and reports
  • Proficiency in requirements management, risk-based testing approaches, defect tracking, and configuration control tools
  • Practical understanding of test methodologies and test engineering best practices
  • Experience working with electro-mechanical equipment and devices
  • Experience selecting test and measurement devices for suitable use
  • Demonstrated capability to solve technical problems
  • Programming experience (general)
  • Experience working with MS SQL databases
  • Familiar with engineering process improvement methodologies
  • Experience managing multiple tasks and priorities simultaneously and adapt to changes in program priorities
  • Demonstrated communication and interpersonal skills to conduct business with cross functional teams
  • High proficiency in MS Excel, Word, PowerPoint, Project applications
  • Ability to exercise flexible work schedule to assure timely project completions
  • 5% – 20% U.S. and international travel

Desired:
  • Experience with product development per FDA design control and ISO 13485 desired
  • Experience with automation tools for testing applications
  • Knowledge of clinical chemistry medical devices or other equipment experience involving complex, multi-component systems
  • Test experience in medical or military products
  • Write scripts and develop other infrastructure for automated software test fixtures
  • SAP, Documentum, Sharepoint, Microsoft Team Foundation Server (TFS), Apache Subversion (SVN), Software Change Management Systems, Microsoft Test Manager (MTM), Microsoft Test Stand,
  • Labview experience

Vacancy expired!


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