Quality Engineer

We are seeking a Quality Engineer to provide Quality Assurance support for day-to-day manufacturing operations within a regulated medical device manufacturing environment. This role serves as the primary Quality representative for the assigned manufacturing line, partnering closely with Production, Manufacturing Engineering, Investigation Engineers, and cross-functional teams to ensure product quality, regulatory compliance, and continuous process improvement.

The successful candidate will oversee procedural readiness, support manufacturing investigations, lead quality improvement initiatives, manage change control activities, participate in validation efforts, and ensure compliance with Quality Management System (QMS) requirements and applicable regulatory standards.

• 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.
  

Requirements

• Bachelor's Degree in Engineering.
  

Experience

• Minimum of 2 years of experience in Quality Engineering and/or Quality Compliance.
  
• Experience in a regulated manufacturing environment, preferably within the medical device industry.
  
• Fully bilingual (English and Spanish), both written and verbal.
  
• Knowledge of FDA, GMP, ISO, and applicable U.S. and international regulations.
  
• Strong understanding of Quality Engineering principles and Quality Management Systems (QMS).
  
• 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 analytical, organizational, and problem-solving skills.
  
• Excellent written, verbal, and interpersonal communication skills.
  
• Ability to evaluate complex manufacturing processes.
  
• Ability to collaborate effectively with employees at all organizational levels.
  

• Medical device manufacturing experience.
  
• Experience with Technical Writing.
  
• Experience supporting validation activities, including IQ/OQ/PQ.
  
• Knowledge of Validation Management Systems.
  
• Experience with Risk Analysis and FMEA.
  
• Knowledge of GIL processes.
  
• Experience leading continuous improvement initiatives.
  
• Project management experience.
  

• Quality Assurance
  
• Quality Engineering
  
• Manufacturing Support
  
• Quality Compliance
  
• Technical Writing
  
• Change Control
  
• Change Management
  
• CAPA
  
• Non-conformance Management
  
• Root Cause Analysis
  
• Process Validation (IQ/OQ/PQ)
  
• Validation Documentation
  
• Risk Analysis
  
• FMEA
  
• FDA Regulations
  
• GMP
  
• ISO Standards
  
• Continuous Improvement
  
• Cross-Functional Collaboration
  
• Problem Solving
  
• Project Coordination