NPI Quality Engineer - Medical Device Launch Lead

Knowles

Lapu-Lapu

On-site

PHP 600,000 - 900,000

Full time

2 days ago

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Job summary

Knowles is seeking a Quality Engineer - NPI to lead quality activities during New Product Introduction in a regulated medical device environment. You will partner with Engineering, Manufacturing, Operations, and Supplier Quality to ensure robust controls and successful product launches.

You will manage validation, risk, and compliance activities, drive investigations, and mentor teams while maintaining audit-ready documentation and traceability across DVT, PVT, and mass trials.

Qualifications

Minimum 3–5 years of Quality Engineering in a regulated manufacturing environment.
Hands-on NPI exposure, IQ/OQ/PQ, TMV, MSA, and qualification of products, processes.
Strong knowledge of ISO 13485, ISO 14971, GMP, and regulatory audits.
Collaborative with cross-functional teams; supervisory experience is a plus.

Responsibilities

Lead NPI Quality & Product Readiness across DVT, PVT, and Mass Trial.
Drive validation activities including IQ/OQ/PQ, TMV, MSA, supplier qualification.
Lead investigations, MRB/NCMR, and corrective actions using 8D, RCCA, 5 Why, Fishbone, and DOE.
Monitor quality metrics and drive continuous improvement for product launches.

Skills

Quality engineering

NPI

Risk management

Data analysis

Cross-functional collaboration

Leadership

Education

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

Tools

Minitab

RCCA

DOE

5 Why

Fishbone diagram

Job description

You will manage validation, risk, and compliance activities, drive investigations, and mentor teams while maintaining audit-ready documentation and traceability across DVT, PVT, and mass trials.

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