Quality Engineer - NPI (MedTech)

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, an Executive Recruitment firm, is partnering with an organisation in the Healthcare industry to hire a Quality Engineer - NPI. This opportunity is based in Cebu, Philippines.

Position Overview

Lead quality activities throughout new product introduction to ensure successful launches within a regulated medical device manufacturing environment.

Drive compliance, validation, risk management, and cross-functional quality excellence to meet customer, regulatory, and business requirements.

Key Responsibilities

• Responsible for leading quality activities during new product introduction and ensuring successful product launches in a regulated medical device manufacturing environment.
• Oversees process validation, product and process qualification, quality risk management, and compliance with medical device standards such as ISO 13485 and ISO 14971.
• Works closely with Engineering, Manufacturing, Operations, and Supplier Quality teams to ensure products and processes meet customer, regulatory, and quality requirements.

Key Requirements

Qualifications & Experience

• Bachelor's Degree in Electronics, Electrical, or a related Engineering discipline.
• Minimum of 3-5 years of Quality Engineering experience in a regulated manufacturing environment.
• Medical device manufacturing experience is highly preferred.

Technical / Functional Expertise

• Hands-on experience in New Product Introduction (NPI), process validation (IQ/OQ/PQ), Test Method Validation (TMV), and Measurement System Analysis (MSA).
• Knowledge of medical device quality standards, particularly ISO 13485, ISO 14971, and GMP.
• Familiarity with FMEA, SPC, GR&R, 8D, Root Cause Analysis, and other quality improvement tools.

Soft Skills & Leadership Competencies

• Strong analytical and problem-solving skills.
• Effective communication and cross-functional collaboration skills.