Quality Consulting Group, LLC
JT772 - SR. SOFTWARE QUALITY ENGINEER
Quality Consulting Group, LLC, Juncos, Juncos, us, 00777
Overview
QUALITY CONSULTING GROUP, a leader inthe 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 ).
Qualifications
Bachelor's degree in
Mechanical, Electrical or Computer/Software preferred (not Science)or Programming
Minimum of 5 years of relevant experience on field (quality –
excluding experience laboratory micro/chemistry ) or engineering or programming
Experience with
Risk management documentation: pFMEAs
Investigation and root cause analysis 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 1stand 2ndshifts and weekends (it will depend on production schedule – projects will be executed at different time shifts, sometimes on weekends)
Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity,, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
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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 ).
Qualifications
Bachelor's degree in
Mechanical, Electrical or Computer/Software preferred (not Science)or Programming
Minimum of 5 years of relevant experience on field (quality –
excluding experience laboratory micro/chemistry ) or engineering or programming
Experience with
Risk management documentation: pFMEAs
Investigation and root cause analysis 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 1stand 2ndshifts and weekends (it will depend on production schedule – projects will be executed at different time shifts, sometimes on weekends)
Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity,, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
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