Quality Consulting Group, LLC
JT095 - PRIN SOFTWARE QUALITY ENGINEER
Quality Consulting Group, LLC, Juncos, Juncos, us, 00777
Overview
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, changes 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. Qualifications
Bachelor’s degree in Engineering:
Mechanical, Electrical or Computer/Software preferred (not Science)or Programming Minimum of
7 years of experience
on field (quality – excluding experience laboratory micro/chemistry) or engineering or programming Experience with Risk management documentation:
pFMEAs Basic knowledge in PLC, general programming, Source Code Review (e.g.
Automation/ Controls / Programming hands on experience ) Computer Software validations/GAMP knowledge – hands on experience Basic knowledge in Root Cause Analysis CAPA/ Investigations/ Root Cause Analyses/Technical Writing Basic knowledge in designing validation strategies (e.g requirements flow down from design to manufacturing) Perform and/or review process validation
(not cleaning processes) and equipment documents:
URS, FAT, IQ, OQ, PQ, TMV
(not laboratory) Knowledge in Medical Devices regulations Knowledge in GAMP Shift:
1stand 2ndshift and weekends (it will depend on production schedule – projects will be executed at different time shifts; sometimes on weekends. Seniority level
Mid-Senior level Employment type
Temporary Job function
Information Technology Industries
Wireless Services, Telecommunications, and Communications Equipment Manufacturing Referrals increase your chances of interviewing at Quality Consulting Group, LLC by 2x Get notified about new Software Quality Engineer jobs in
Juncos, Puerto Rico . College Program: Associate Software Engineer
San Juan, Puerto Rico $60,000.00-$120,000.00 2 months ago Principle Software Quality Engineer - 114
San Juan, Puerto Rico $120,000.00-$180,000.00 1 month ago San Juan, Puerto Rico $80,000.00-$120,000.00 2 months ago LL01-100824 Validation Engineer (1-3 years of experience)
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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, changes 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. Qualifications
Bachelor’s degree in Engineering:
Mechanical, Electrical or Computer/Software preferred (not Science)or Programming Minimum of
7 years of experience
on field (quality – excluding experience laboratory micro/chemistry) or engineering or programming Experience with Risk management documentation:
pFMEAs Basic knowledge in PLC, general programming, Source Code Review (e.g.
Automation/ Controls / Programming hands on experience ) Computer Software validations/GAMP knowledge – hands on experience Basic knowledge in Root Cause Analysis CAPA/ Investigations/ Root Cause Analyses/Technical Writing Basic knowledge in designing validation strategies (e.g requirements flow down from design to manufacturing) Perform and/or review process validation
(not cleaning processes) and equipment documents:
URS, FAT, IQ, OQ, PQ, TMV
(not laboratory) Knowledge in Medical Devices regulations Knowledge in GAMP Shift:
1stand 2ndshift and weekends (it will depend on production schedule – projects will be executed at different time shifts; sometimes on weekends. Seniority level
Mid-Senior level Employment type
Temporary Job function
Information Technology Industries
Wireless Services, Telecommunications, and Communications Equipment Manufacturing Referrals increase your chances of interviewing at Quality Consulting Group, LLC by 2x Get notified about new Software Quality Engineer jobs in
Juncos, Puerto Rico . College Program: Associate Software Engineer
San Juan, Puerto Rico $60,000.00-$120,000.00 2 months ago Principle Software Quality Engineer - 114
San Juan, Puerto Rico $120,000.00-$180,000.00 1 month ago San Juan, Puerto Rico $80,000.00-$120,000.00 2 months ago LL01-100824 Validation Engineer (1-3 years of experience)
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr