JT095 - PRIN SOFTWARE QUALITY ENGINEER

Quality Consulting Group • Juncos, PR

11d

About The Position

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.

Requirements

• 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

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 51-100 employees