NPI Quality Engineer — Medtech Launch Leader

Knowles Corporation; Lapu-Lapu; On-site; PHP 600,000 - 1,100,000; Full time

Job summary

Knowles Corporation seeks a Quality Engineer – NPI (Medtech) to lead quality activities during New Product Introduction in a regulated medical device environment. You will collaborate with Engineering, Manufacturing, Operations, Program Management and Supplier Quality to establish robust controls, execute validations, and ensure compliance throughout product development and commercialization.

The role requires 3–5 years in quality engineering, hands‑on NPI and validation experience, and strong

Qualifications

• 3–5 years of Quality Engineering in a regulated manufacturing environment.
• Experience in NPI and process validation (IQ/OQ/PQ).
• Knowledge of ISO 13485, ISO 14971, GMP, and regulatory audits.
• Collaborative with cross‑functional teams; supervisory experience a plus.

Responsibilities

• Lead NPI quality and product readiness across DVT, PVT, Mass Trial.
• Drive validation activities and supplier qualification.
• Maintain audit‑ready documentation and product traceability.
• Investigate quality issues and drive 8D/5 Why/DOE.
• Monitor quality metrics and drive continuous improvement.

Skills

NPI

Quality engineering

Cross-functional collaboration

Risk management

Quality system knowledge

Education

Bachelor's degree in Electronics/Electrical or related Engineering

Tools

IQ/OQ/PQ

TMV

MSA

RCCA/8D

FMEA

DOE

Job description

Knowles Corporation seeks a Quality Engineer – NPI (Medtech) to lead quality activities during New Product Introduction in a regulated medical device environment. You will collaborate with Engineering, Manufacturing, Operations, Program Management and Supplier Quality to establish robust controls, execute validations, and ensure compliance throughout product development and commercialization.

The role requires 3–5 years in quality engineering, hands‑on NPI and validation experience, and strong