NPI Quality Engineer — Medtech Launch & Compliance Lead

Knowles; Lapu-Lapu; On-site; PHP 600,000 - 800,000; Full time

Job summary

Knowles is seeking a Quality Engineer – NPI to lead quality efforts during the New Product Introduction phases in a regulated medical device manufacturing environment.

This role involves working with various teams to establish process controls, manage quality risks, and ensure compliance with medical device standards. The ideal candidate will have a Bachelor's degree in a relevant field and 3-5 years of experience in quality engineering, particularly within the medical device industry.

Qualifications

• Minimum 3–5 years of Quality Engineering experience in a regulated manufacturing environment.
• Hands-on experience in NPI, process validation (IQ/OQ/PQ), and product qualification.
• Strong knowledge of medical device quality systems and regulatory compliance.

Responsibilities

• Lead quality activities during New Product Introduction (NPI).
• Execute and support qualification and validation activities.
• Lead investigations and implement corrective actions.

Skills

Quality Engineering

NPI

Process Validation

Regulatory Compliance

Problem Solving

Education

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

Tools

Minitab

Lean Manufacturing

Six Sigma

Job description

Knowles is seeking a Quality Engineer – NPI to lead quality efforts during the New Product Introduction phases in a regulated medical device manufacturing environment.

This role involves working with various teams to establish process controls, manage quality risks, and ensure compliance with medical device standards. The ideal candidate will have a Bachelor's degree in a relevant field and 3-5 years of experience in quality engineering, particularly within the medical device industry.