Quality Assurance Lead - Medical Devices (Bilingual)

Medial Group; Barceloneta (PR); On-site; USD 70,000 - 90,000; Full time

Job summary

Medial Group in Barceloneta, Puerto Rico seeks a Quality Engineer to provide QA support for day-to-day manufacturing operations in a regulated medical device environment. You will serve as the primary QA representative for the line, partnering with production, engineering, and investigation teams to ensure product quality and regulatory compliance.

The role involves overseeing procedural readiness, supporting investigations, leading quality improvement initiatives, managing change control

Qualifications

• Bachelor's Degree in Engineering.
• Minimum of 2 years of experience in Quality Engineering and/or Quality Compliance.
• Fully bilingual English and Spanish.
• Knowledge of FDA, GMP, ISO, and applicable U.S. and international regulations.
• Strong analytical, organizational and problem-solving skills.
• Experience supporting Change Control and Change Management processes.
• Knowledge of product quality planning, risk analysis, and quality documentation.
• Experience supporting investigations, CAPA, and non-conformance management.
• Ability to prepare technical documentation and engineering reports.
• Strong written, verbal, and interpersonal communication skills.
• Ability to evaluate complex manufacturing processes.
• Ability to collaborate effectively with employees at all organizational levels.

Responsibilities

• Serve as the primary Quality Assurance representative supporting daily manufacturing operations.
• Partner with Line Supervisors, Manufacturing Engineers, Investigation Engineers, and Service Engineers to resolve quality issues and improve manufacturing performance.
• Ensure procedural readiness through execution, monitoring, and remediation of manufacturing processes.
• Monitor, track, and report quality metrics and quality improvement initiatives.
• Lead Quality Improvement projects from initiation through implementation and sustainability.
• Initiate, coordinate, and support Change Requests (CR) and Change Orders (CO) through the Change Management System.
• Support Quality Investigation Engineers with investigations, non-conformances, root cause analysis, and corrective actions.
• Evaluate and document manufacturing non-conformances in accordance with Quality System requirements.
• Develop, review, and maintain quality plans, quality documentation, and quality systems.
• Participate in product risk assessments, FMEAs, and quality planning activities.
• Perform quality impact assessments for engineering and manufacturing changes.
• Write, review, and approve engineering study, qualification, validation, and verification protocols and reports with minimal supervision.
• Support equipment, process, and product validation activities (IQ/OQ/PQ) and maintain validation documentation.
• Utilize validation management systems to support qualification and validation activities.
• Monitor project progress and ensure deliverables are completed according to schedule.
• Evaluate manufacturing processes and recommend continuous improvement opportunities.
• Collaborate effectively with cross-functional teams to resolve quality and compliance issues.
• Ensure compliance with FDA, ISO, GMP, and other applicable U.S. and international regulatory requirements.

Skills

Quality Assurance

Regulatory compliance

Root cause analysis

Change control

Documentation

Cross-functional collaboration

Bilingual English/Spanish

Analytical thinking

Education

Bachelor's Degree in Engineering

Job description

Medial Group in Barceloneta, Puerto Rico seeks a Quality Engineer to provide QA support for day-to-day manufacturing operations in a regulated medical device environment. You will serve as the primary QA representative for the line, partnering with production, engineering, and investigation teams to ensure product quality and regulatory compliance.

The role involves overseeing procedural readiness, supporting investigations, leading quality improvement initiatives, managing change control