Quality Engineering Manager - Medical Devices

Maclivaro Limited; Miami (FL); On-site; USD 140,000 - 190,000; Full time

Job summary

Maclivaro Limited in Miami, FL, is seeking a Quality Engineering Manager to lead design controls, risk management and regulatory compliance across the product lifecycle. This hands-on leadership role couples technical depth with practical problem-solving to ensure medical devices are developed and manufactured to the highest quality standards.

You will collaborate with R&D, manufacturing and regulatory teams, shaping the QMS, CAPA program and readiness for FDA inspections, ISO 13485, and design

Qualifications

• Experience in medical device quality with design controls and regulatory compliance.
• Hands-on leadership in quality engineering across product development lifecycle.
• Experience with FDA QMSR, ISO 13485 and risk management principles.

Responsibilities

• Lead quality engineering activities across product development lifecycle.
• Ensure design controls and risk management are integrated into development plans.
• Oversee CAPA, non-conformance, investigations and continuous improvement initiatives.
• Support regulatory submissions, inspections and audits.

Skills

Quality engineering

Design controls

Regulatory compliance

Leadership

Risk management

Job description

Maclivaro Limited in Miami, FL, is seeking a Quality Engineering Manager to lead design controls, risk management and regulatory compliance across the product lifecycle. This hands-on leadership role couples technical depth with practical problem-solving to ensure medical devices are developed and manufactured to the highest quality standards.

You will collaborate with R&D, manufacturing and regulatory teams, shaping the QMS, CAPA program and readiness for FDA inspections, ISO 13485, and design