Principal Software Quality Engineer

Medial Group; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Medial Group in Juncos, Puerto Rico, seeks a senior QA/Validation Engineer to lead software quality, validation strategies, and regulatory compliance for medical devices. You will design test plans, oversee design reviews, and mentor team members on-site.

The role requires advanced knowledge of CAPA, risk management (PFMEA), and documentation, with strong technical writing and leadership skills for cross-functional projects.

Qualifications

• Experience in quality engineering and regulatory submissions for medical devices.
• Knowledge of CAPA, PFMEA, risk management and validation strategies.
• Ability to design validation plans and write technical documentation.

Responsibilities

• Develop, modify, apply, and maintain software quality standards and procedures.
• Evaluate software activities from requirements to validation and release.
• Define measures to ensure product quality and regulatory compliance.
• Review designs, change specs, and project plans against requirements.
• Lead projects end-to-end and coordinate with stakeholders.
• Provide mentorship and training to team members.

Skills

CAPA

Root cause analysis

Technical writing

Process validation

Software validation

Statistical analysis

PFMEA

Regulatory knowledge

Documentation

Project leadership

Education

Bachelor's degree in Engineering

Tools

Rx Logix PLC

Vision Systems

Instrumentation

Control Systems

SQL

Python

R

FactoryTalk

RSView

NoSQL databases

Data management

Operating Systems

Job description

Juncos, Puerto Rico

Responsibilities may include the following and other dutiesmay be assigned:

• Develop,modify, apply, and maintain standards for software systems qualityoperating methods, processes, and procedures.
  
• Conductevaluation of software systems activities including requirements, design,development, documentation, integration, test, verification, andvalidation.
  
• Defineand implement appropriate measures to ensure product quality.
  
• Reviewsoftware systems design, change specifications, and project plans againstcontractual and regulatory requirements.
  
• Ensurecompliance with applicable specifications, tools, techniques, andmethodologies.
  
• Provideor direct verification and validation of software system requirements,traceability, and testability.
  
• Leadand oversee projects from design to implementation, ensuring compliancewith policies and industry regulations.
  
• Representthe organization as primary contact for projects/initiatives,communicating with internal and external stakeholders.
  
• Providementorship, coaching, and training to other professionals within the team.
  

Requirements

Experience

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.

• 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

Bachelor’s degree in Engineering (Mechanical, Electrical, or Computer/Software preferred).

Technical Skills

Must Have

• Investigationand root cause analysis skills
  
• Technicalwriting knowledge
  
• Strongorganizational and communication skills
  
• Processvalidation and computer software validation knowledge
  
• Abilityto apply statistical techniques to analyze data and develop/review/approvetest plans and reports
  
• Interpersonalskills to support product disposition investigations (PFMEA, atypicalevents)
  
• Automatedsource code management
  
• Computersoftware programming (including embedded software programming)
  
• Developmentof control plans and PFMEA
  

Additional Technical Areas (Hands-On/Knowledge Required)

• ProgrammableLogic Controllers (PLC): Rx Logix configuration & troubleshooting
  
• VisionSystems
  
• Instrumentation: overview and application
  
• ControlSystems
  
• DataStructure & Sources
  
• DataAnalysis Tools: SQL, Python, R
  
• DataManagement
  
• Databases: data extraction, transformation, loading, database creation/maintenance,query overview (SQL/Non-SQL)
  
• GUI/HMIDesign: FactoryTalk, RSView
  
• CommunicationNetworks
  
• OperatingSystems
  
• FDACSA Guidance: knowledge of Computer Software Assurance (CSA) forproduction and quality system software (FDA Draft Guidance, 2022)
  

Nice to Have

• Additionalinvestigation and root cause analysis expertise
  

*Willing to work 1st or 2nd shift and 100% on-Site in Juncos.*