Conde InduServices Corp.
Principal Software Quality Engineer ( 1st & 2nd Shift) Juncos, Puerto Rico
Conde InduServices Corp., Juncos, Juncos, us, 00777
Responsibilities may include the following and other duties may be assigned:
Develop, modify, apply, and maintain standards for software systems quality operating methods, processes, and procedures.
Conduct evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification, and validation.
Define and implement appropriate measures to ensure product quality.
Review software systems design, change specifications, and project plans against contractual and regulatory requirements.
Ensure compliance with applicable specifications, tools, techniques, and methodologies.
Provide or direct verification and validation of software system requirements, traceability, and testability.
Lead and oversee projects from design to implementation, ensuring compliance with policies and industry regulations.
Represent the organization as primary contact for projects/initiatives, communicating with internal and external stakeholders.
Provide mentorship, coaching, and training to other professionals within the team.
Experience Requirements:
Minimum 7 years of relevant experience in quality, engineering, or programming (excluding laboratory micro/chemistry experience).
Advanced degree accepted with minimum 5 years of relevant experience.
Automation / Controls / Programming hands-on experience
CAPA, investigations, root cause analysis, and technical writing
Computer software validations and GAMP knowledge – hands-on experience
(Additional) Strong knowledge in medical devices regulations
Experience with risk management documentation (PFMEAs)
Experience designing validation strategies (e.g., requirements flow down from design to manufacturing)
Perform and/or review process validation and equipment documents: URS, FAT, IQ, OQ, PQ, TMV (not cleaning or laboratory processes)
Knowledge of medical device regulations and GAMP standards
Education Requirement:
Bachelor’s degree in Engineering (Mechanical, Electrical, or Computer/Software preferred).
Technical Skills (Must Have)
Investigation and root cause analysis skills
Technical writing knowledge
Strong organizational and communication skills
Process validation and computer software validation knowledge
Ability to apply statistical techniques to analyze data and develop/review/approve test plans and reports
Experience in medical devices manufacturing
Interpersonal skills to support product disposition investigations (PFMEA, atypical events)
Automated source code management
Computer software programming (including embedded software programming)
Development of control plans and PFMEA
Additional Technical Areas (Hands-On/Knowledge Required)
Programmable Logic Controllers (PLC): Rx Logix configuration & troubleshooting
Vision Systems
Instrumentation: overview and application
Control Systems
Data Structure & Sources
Data Analysis Tools: SQL, Python, R
Data Management
Databases: data extraction, transformation, loading, database creation/maintenance, query overview (SQL/Non-SQL)
Programming: Assembly (C), Object-Oriented Programming (Python, Java), error handling, abstract data types
GUI/HMI Design: FactoryTalk, RSView
Communication Networks
Operating Systems
FDA CSA Guidance: knowledge of Computer Software Assurance (CSA) for production and quality system software (FDA Draft Guidance, 2022)
Nice to Have
Additional investigation and root cause analysis expertise
Work Methodology:
Full time contract
100% on-site job in Medtronic- Juncos, PR
First contract until August 2026 based to performance and budget availability.
Willing to work 1st or 2nd shift
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Develop, modify, apply, and maintain standards for software systems quality operating methods, processes, and procedures.
Conduct evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification, and validation.
Define and implement appropriate measures to ensure product quality.
Review software systems design, change specifications, and project plans against contractual and regulatory requirements.
Ensure compliance with applicable specifications, tools, techniques, and methodologies.
Provide or direct verification and validation of software system requirements, traceability, and testability.
Lead and oversee projects from design to implementation, ensuring compliance with policies and industry regulations.
Represent the organization as primary contact for projects/initiatives, communicating with internal and external stakeholders.
Provide mentorship, coaching, and training to other professionals within the team.
Experience Requirements:
Minimum 7 years of relevant experience in quality, engineering, or programming (excluding laboratory micro/chemistry experience).
Advanced degree accepted with minimum 5 years of relevant experience.
Automation / Controls / Programming hands-on experience
CAPA, investigations, root cause analysis, and technical writing
Computer software validations and GAMP knowledge – hands-on experience
(Additional) Strong knowledge in medical devices regulations
Experience with risk management documentation (PFMEAs)
Experience designing validation strategies (e.g., requirements flow down from design to manufacturing)
Perform and/or review process validation and equipment documents: URS, FAT, IQ, OQ, PQ, TMV (not cleaning or laboratory processes)
Knowledge of medical device regulations and GAMP standards
Education Requirement:
Bachelor’s degree in Engineering (Mechanical, Electrical, or Computer/Software preferred).
Technical Skills (Must Have)
Investigation and root cause analysis skills
Technical writing knowledge
Strong organizational and communication skills
Process validation and computer software validation knowledge
Ability to apply statistical techniques to analyze data and develop/review/approve test plans and reports
Experience in medical devices manufacturing
Interpersonal skills to support product disposition investigations (PFMEA, atypical events)
Automated source code management
Computer software programming (including embedded software programming)
Development of control plans and PFMEA
Additional Technical Areas (Hands-On/Knowledge Required)
Programmable Logic Controllers (PLC): Rx Logix configuration & troubleshooting
Vision Systems
Instrumentation: overview and application
Control Systems
Data Structure & Sources
Data Analysis Tools: SQL, Python, R
Data Management
Databases: data extraction, transformation, loading, database creation/maintenance, query overview (SQL/Non-SQL)
Programming: Assembly (C), Object-Oriented Programming (Python, Java), error handling, abstract data types
GUI/HMI Design: FactoryTalk, RSView
Communication Networks
Operating Systems
FDA CSA Guidance: knowledge of Computer Software Assurance (CSA) for production and quality system software (FDA Draft Guidance, 2022)
Nice to Have
Additional investigation and root cause analysis expertise
Work Methodology:
Full time contract
100% on-site job in Medtronic- Juncos, PR
First contract until August 2026 based to performance and budget availability.
Willing to work 1st or 2nd shift
#J-18808-Ljbffr