Senior Software Quality Engineer - Medical Devices On-Site

Medial Group; Juncos (PR); Vor Ort; USD 90.000 - 130.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

CAPA

Root cause analysis

Technical writing

Process validation

Software validation

Statistical analysis

PFMEA

Regulatory knowledge

Documentation

Project leadership

Ausbildung

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

Jobbeschreibung

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.