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Posted 3d ago

Software Quality Engineering Consultant II - Medical Device #2104

@ ECI
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Alajuela, Alajuela, Costa Rica
OnsiteFull Time
Responsibilities:Validation planning, Risk analysis, User needs definition
Requirements Summary:Bachelor’s degree in Engineering; four years of experience; advanced computer skills (MS Office, Minitab); familiar with electronic documentation; Spanish native, English fluent; willing to perform on-site work.
Technical Tools Mentioned:Microsoft Office, MS Project, MS Visio, Minitab
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Job Description

 

About ECI

 

ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges and we take pride in providing them transformative solutions with distinctive, sustainable and long term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.

 

About this role

 

Assist the Quality team with the validation of a new software for the calibrations area per 21 CFR Part 11 and GAMP 5. This software will be implemented in 3 phases, as follows:

 

What You'll Do

 

  • Validation Planning: assist in creating a master document that defines the scope, resources, acceptance criteria, and specific tasks for the entire lifecycle.
  • Risk Analysis & Management: identifying potential software-related hazards and implementing mitigations, such as fail-safe code or alarm systems.
  • User Needs Definition: documenting high-level requirements (User Requirements Specification - URS)
  • Qualification Stages (IQ/OQ/PQ):
    • Installation Qualification (IQ): verifying the software is installed correctly in its environment. Assist in writing the IQ Protocol, executing the protocol and writing the IQ Report.
    • Operational Qualification (OQ): Testing software functions against technical specifications under normal and "challenge" conditions. Assist in writing the OQ Protocol, executing the protocol and writing the OQ Report.
    • Performance Qualification (PQ): Confirming the system performs reliably under actual or simulated real-world usage over time. Assist in writing the PQ Protocol, executing the protocol and writing the PQ Report.
  • User Acceptance Testing (UAT): having representative end-users test the software in its intended environment to ensure it is intuitive and effective.
  • Prepare and maintain a Project Tracker with weekly updates for Management Review.
  • Knowledge transfer to client during and at completion of the project.
  • Other tasks as agreed upon between the Liaisons listed in this Statement of Work.

 

 

What We're Looking For

 

  • Bachelor’s Degree in Engineering.
  • 4 years of experience.
  • Advanced computer skills including MS Office applications (Word/Excel/PowerPoint/Project/Visio) 
    Proficient in the use of Minitab statistical analysis.
  • Familiar with electronic management documentation.
  • Spanish: Native Speaker, English: Fluent speaking, writing and reading.

 

 

 

ECI is an equal opportunity employer.

All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.

 

 

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