Software Quality Engineer II

Medial Group; Juncos (PR); In loco; USD 70.000 - 110.000; Tempo pieno

Descrizione del lavoro

Medial Group in Juncos, Puerto Rico, seeks a Quality Engineer to develop and maintain software quality standards across the project lifecycle. You will evaluate software activities from requirements through validation, define quality measures, and ensure compliance with contracts and regulatory guidelines.

Responsibilities include reviewing designs, validating systems, and supporting CAPA investigations. Minimum 3 years in quality, engineering, or programming in regulated industries is expected,

Competenze

• Minimum 3 years of field experience in Quality, Engineering, or Programming in the regulated industry.
• Experience with risk management documentation (pFMEAs).
• Basic knowledge in PLC, general programming, and source code review.
• Ability to support CAPA investigations and provide technical writing.
• Knowledge of designing and reviewing validation strategies (requirements flow down from design to manufacturing).
• Ability to perform and/or review process/equipment validation documentation: URS, FAT, IQ, OQ, PQ, TMV (not laboratory).
• Familiarity with Medical Device Regulations and GAMP guidelines.

Mansioni

• Develop, modify, apply, and maintain standards for software systems quality operating methods, processes, and procedures.
• Conduct evaluations of software systems activities including requirements, design, development, documentation, integration, testing, verification, and validation.
• Define appropriate measures to ensure product quality.
• Develop overall operating criteria to ensure implementation of the software quality program in compliance with project, process, and contract requirements.
• Ensure project and process control documentation meet requirements, objectives, and/or contracts.
• Review software systems design, change specifications, and plans against contractual and/or process requirements.
• Assess specifications, materials, tools, techniques, and methodologies for compliance.
• Provide or direct verification and validation of software system requirements, traceability, and testability.
• Perform other duties as assigned.

Conoscenze

Investigation & RCAs

Technical writing

Organizational skills

Process validation

Statistics & data analysis

Medical device manufacturing

CAPA investigations

PFMEA development

Automated source control

Software programming

Embedded software programming

Control plans & PFMEA

Descrizione del lavoro

Juncos, Puerto Rico

• Develop, modify, apply, and maintain standards for software systems quality operating methods, processes, and procedures.
  
• Conduct evaluations of software systems activities including requirements, design, development, documentation, integration, testing, verification, and validation.
  
• Define appropriate measures to ensure product quality.
  
• Develop overall operating criteria to ensure implementation of the software quality program in compliance with project, process, and contract requirements.
  
• Ensure project and process control documentation meet requirements, objectives, and/or contracts.
  
• Review software systems design, change specifications, and plans against contractual and/or process requirements.
  
• Assess specifications, materials, tools, techniques, and methodologies for compliance.
  
• Provide or direct verification and validation of software system requirements, traceability, and testability.
  
• Perform other duties as assigned.
  

Requirements

• Minimum 3 years of field experience in Quality, Engineering, or Programming in the regulated industry.
  
• Experience with risk management documentation (pFMEAs).
  
• Basic knowledge in PLC, general programming, and source code review.
  
• Ability to support CAPA investigations and provide technical writing.
  
• Knowledge of designing and reviewing validation strategies (requirements flow down from design to manufacturing).
  
• Ability to perform and/or review process/equipment validation documentation: URS, FAT, IQ, OQ, PQ, TMV (not laboratory).
  
• Familiarity with Medical Device Regulations and GAMP guidelines.
  

Technical Skills (Must Have)

• Investigation and root cause analysis skills.
• Technical writing knowledge.
• Strong organization and communication skills.
• Process validation and computer software validation knowledge.
• Ability to use statistical techniques to analyze data.
• Experience in medical device manufacturing.
• Interpersonal skills to investigate and collaborate in atypical event investigations.
• pFMEA development and review.
• Automated source code management.
• Computer software programming.
• Embedded software programming.
• Development of control plans and PFMEA.

Nice to Have

• Additional experience with investigation and root cause analysis.

Top 3 Priorities in Candidate's Experience

• Automation, controls, and programming hands-on experience.
• CAPA, investigations, root cause analysis, and technical writing.
• Computer software validations and GAMP knowledge (hands-on).

*Willing to work 100% On-site in Juncos, 1st and 2nd shift.*