Manufacturing Software Engineer I - Validation & QA

Quality Consulting Group, LLC; Northern (KY); Hybrid; USD 85,000 - 110,000; Full time

Job summary

Quality Consulting Group, LLC seeks a highly motivated engineer to perform CSV on production-relevant computers in a regulated manufacturing environment. You will validate EC/EF revisions, prepare protocols, and report outcomes for manufacturing deployments, working with FW Pulse projects and MSCM procedures.

The role requires a Bachelor’s in Engineering, 2+ years in regulated industry, and strong English/Spanish technical communication skills, with knowledge of Windows installations and SDLC

Qualifications

• Bachelor’s degree in Engineering required.
• At least two years’ experience in regulated industry with software validations.
• Root cause analysis and technical writing skills required.
• Experience with waterfall SDLC expected.
• Experience in medical devices or regulated industries.
• Strong written and verbal technical English/Spanish communications.
• Ability to develop software qualification protocols and reports.
• Familiar with Windows 10/11 software installation and troubleshooting.

Responsibilities

• Perform CSV on computers reserved for FW Pulse with a revision of EC/EF different from production.
• Prepare CSV protocols, execute them, and prepare reports validating EC/EF equivalence.
• Work with FW Pulse project and related ancillary software.
• Use MSCM-validated components and follow the Global IT MSCM Procedure for CSV.
• Design manufacturing processes, procedures, and layouts for assemblies and equipment installation.
• Ensure processes and procedures comply with regulations.

Skills

Investigation and root cause analysis

Technical writing

Organization and communication

Waterfall/SDLC

Regulated industry experience

English/Spanish communication

Software qualification protocols

Windows troubleshooting

Education

Bachelor’s degree in Engineering

Job description

Quality Consulting Group, LLC seeks a highly motivated engineer to perform CSV on production-relevant computers in a regulated manufacturing environment. You will validate EC/EF revisions, prepare protocols, and report outcomes for manufacturing deployments, working with FW Pulse projects and MSCM procedures.

The role requires a Bachelor’s in Engineering, 2+ years in regulated industry, and strong English/Spanish technical communication skills, with knowledge of Windows installations and SDLC