Jt773 - Software Quality Engr Ii
Quality Consulting Group, Llc
- Juncos, PR
- Temporal
- Tiempo completo
QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you'll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.*Responsibilities*
- Develops, modifies, applies, and maintains standards for software systems quality operating methods, processes, and procedures.
- Conducts evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification and validation.
- Defines appropriate measures to ensure product quality.
- Develops overall operating criteria to ensure implementation of the software quality program according to project, process and contract requirements and objectives.
- Ensures that projects and process control documentation are compliant with requirements, objectives and/or contracts.
- Reviews software systems design, change specifications, and plans against contractual and/or process requirements.
- Reviews include applicable specifications, materials, tools, techniques, and methodologies.
- Provides or directs verification and validation of software system requirements, traceability, and testability.
- Performs and/or review process validation (not cleaning processes) and equipment documents: URS, FAT, IQ, OQ, PQ, TMV (not laboratory).
- Bachelor's degree in Mechanical, Electrical or Computer/Software preferred (not Science) or Programming
- Minimum of 3 years of relevant experience on field (quality – excluding experience laboratory micro/chemistry) or engineering or programming
- Investigation and root cause analysis skills
- Investigate and collaborate in the investigation of atypical events to support product disposition PFMEA.
- Ability to use statistical techniques to analyze data capable of developing/reviewing/approving test plans and reports experience in Medical Devices.
- Interpersonal skills
- Organization and Communication skills
- Technical writing knowledge
- Knowledge of Process validation and Computer software validation (e.g requirements flow down from design to manufacturing)
- Knowledge of Computer and Embedded Software Programming (e.g GAMP, PLC, general programming, Source Code Review)
- Knowledge of Automated Code Software Management
- Knowledge in Medical Devices regulations
- Availability for 1st and 2nd shifts and weekends (it will depend on production schedule – projects will be executed at different time shifts, sometimes on weekends)
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