NPI Quality Engineer – MedTech Launch Lead

Knowles Electronics (Philippines) Corporation

Central Visayas

On-site

PHP 550,000 - 900,000

Full time

3 days ago
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Benefits offered by this job

Relocation assistance

Job summary

Knowles Electronics (Philippines) Corporation in Cebu City is seeking a Quality Engineer – NPI (MedTech) to lead quality activities during New Product Introduction and ensure successful product launches in a highly regulated medical device environment.

You will collaborate with Engineering, Manufacturing, Operations, and Supplier Quality to establish robust process controls, perform validation, manage risks, and ensure compliance with ISO 13485 and customer requirements throughout development

Qualifications

  • Bachelor’s degree in Electronics, Electrical, or related engineering field.
  • 3–5 years in Quality Engineering in regulated manufacturing, medical device preferred.
  • Experience with NPI, process validation, TMV, MSA, and supplier qualifications.

Responsibilities

  • Lead NPI Quality & Product Readiness across DVT, PVT, and Mass Trial to ensure readiness of materials, processes, equipment, and documentation.
  • Drive qualification, validation, and quality-system activities (IQ/OQ/PQ, TMV, MSA) while ensuring regulatory compliance.
  • Lead investigations,customer escalations, MRB/NCMR activities, and corrective actions using 8D, RCCA, 5 Why, Fishbone, and DOE.

Skills

Quality engineering
NPI
Cross-functional collaboration
Problem solving

Education

Bachelor’s degree in Electronics, Electrical, or related Engineering

Tools

IQ/OQ/PQ
MSA
FMEA
Control Plans
Minitab

Job description

Knowles Electronics (Philippines) Corporation in Cebu City is seeking a Quality Engineer – NPI (MedTech) to lead quality activities during New Product Introduction and ensure successful product launches in a highly regulated medical device environment.

You will collaborate with Engineering, Manufacturing, Operations, and Supplier Quality to establish robust process controls, perform validation, manage risks, and ensure compliance with ISO 13485 and customer requirements throughout development

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