Quality Engineer - Medical Devices, CAPA & CI

JobDiva, Inc.; Miami (FL); On-site; USD 90,000 - 120,000; Full time

Job summary

Creative Solutions Services, LLC in the Miami area is seeking a Quality Assurance professional to ensure product quality, regulatory compliance, and process adherence in medical device manufacturing.

You will lead CAPA, perform root cause analysis, support FDA/ISO audits, manage QMS documentation, and drive Lean Six Sigma initiatives across cross-functional teams.

Qualifications

• Bachelor's degree in engineering or related field.
• Experience in medical device manufacturing preferred.
• Knowledge of regulatory and quality systems.
• Strong communication and cross-functional collaboration skills.

Responsibilities

• Ensure product quality and regulatory compliance by monitoring production.
• Manage non-conformances, deviations, and CAPA activities.
• Perform RCA and implement corrective actions.
• Support FDA/ISO audits.
• Maintain QMS documentation (SOPs, DHF, DMR, DHR).
• Collaborate with manufacturing, engineering, and suppliers.
• Drive Lean Six Sigma improvement initiatives.
• Perform process monitoring and support validation activities (IQ/OQ/PQ as required).
• Ensure proper documentation and traceability of records.

Skills

CAPA management

Root cause analysis

Lean Six Sigma

Quality systems

Cross-functional teamwork

Education

Bachelors in Engineering

Tools

QMS software

Job description

Job Description:

• Responsible for ensuring product quality, regulatory compliance, and process adherence in manufacturing environments by monitoring production activities, managing quality systems, and driving resolution of non-conformances.
• The role involves CAPA management, root cause analysis, audit support, and implementation of continuous improvement initiatives while collaborating with cross-functional teams.

Roles & Responsibilities:

• Monitor manufacturing processes to ensure product quality and compliance with defined standards.
• Manage non-conformances (Client), deviations, and CAPA activities.
• Perform root cause analysis (RCA) and implement corrective and preventive actions.
• Support internal and external audits (FDA, ISO).
• Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and GMP requirements.
• Maintain and update Quality Management System (QMS) documentation including SOPs, DHF, DMR, and DHR.
• Collaborate with manufacturing, engineering, and supplier teams to resolve quality issues.
• Drive continuous improvement initiatives using Lean Six Sigma methodologies.
• Perform process monitoring and support validation activities (IQ/OQ/PQ as required).
• Ensure proper documentation and traceability of manufacturing and quality records.

Education & Experience:

• Bachelor's degree in engineering or a related field.
• Experience in medical device manufacturing preferred.
• Strong understanding of regulatory and quality systems.
• Good communication and cross-functional collaboration skills.
• Manufacturing Quality.
• GMP.
• ISO 13485.
• FDA 21 CFR Part 820.
• CAPA.
• Client.
• Root Cause Analysis (RCA).
• Risk Management (FMEA).
• Statistical Process Control (SPC).
• Audit Compliance.
• Quality Management System (QMS).
• Continuous Improvement.