NPI Quality Engineer – MedTech Devices

Monroe Consulting Group; Cebu City; On-site; PHP 600,000 - 800,000; Full time

Job summary

Monroe Consulting Group is partnering with a healthcare organization in Cebu, Philippines to hire a Quality Engineer - NPI. The role leads quality activities during new product introductions in a regulated medical device environment, ensuring successful launches and robust quality systems.

You will drive validation, risk management, and compliance with ISO 13485, ISO 14971, and GMP, collaborating with Engineering, Manufacturing, and Supplier Quality teams to meet regulatory and customer

Qualifications

• Bachelor's degree in Electronics, Electrical or related engineering field.
• 3–5 years of Quality Engineering in a regulated manufacturing environment.
• Medical device manufacturing experience is highly preferred.

Responsibilities

• Lead quality activities during new product introduction to ensure successful launches.
• Oversee process validation, qualification, and quality risk management.
• Collaborate with Engineering, Manufacturing, Operations and Supplier Quality teams to meet requirements.

Skills

Analytical thinking

Strong problem-solving

Effective communication

Cross-functional collaboration

Education

Bachelor's Degree in Electronics, Electrical, or related Engineering

Tools

ISO 13485

ISO 14971

GMP

Job description

Monroe Consulting Group is partnering with a healthcare organization in Cebu, Philippines to hire a Quality Engineer - NPI. The role leads quality activities during new product introductions in a regulated medical device environment, ensuring successful launches and robust quality systems.

You will drive validation, risk management, and compliance with ISO 13485, ISO 14971, and GMP, collaborating with Engineering, Manufacturing, and Supplier Quality teams to meet regulatory and customer