SOFTWARE QUALITY ENGR II

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) Qualifications:

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)