Quality Engineer – NPI

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

We are looking for a Quality Engineer – NPI (Medtech) to lead quality activities during New Product Introduction (NPI) and ensure successful product launches in a highly regulated medical device manufacturing environment.

In this role, you will work closely with Engineering, Manufacturing, Operations, Program Management, and Supplier Quality teams to establish robust process controls, execute validation activities, manage quality risks, and ensure compliance with medical device standards and customer requirements throughout product development and commercialization.

What You’ll Be Doing

Lead NPI Quality & Product Readiness

• Serve as the Quality Lead throughout DVT, PVT, and Mass Trial phases, ensuring readiness of materials, processes, equipment, test systems, and documentation.
• Partner with R&D, Manufacturing, Test Engineering, Operations, Supplier Quality, and Program Management teams to drive successful product launches and manufacturing transfers.

Drive Validation, Compliance & Quality Systems

• Execute and support qualification and validation activities, including IQ/OQ/PQ, Test Method Validation (TMV), MSA, and supplier/process qualification.
• Ensure compliance with ISO 13485, ISO 14971, GMP, customer, and regulatory requirements while maintaining audit-ready documentation and product traceability.

Resolve Quality Issues & Improve Performance

• Lead investigations, customer escalations, MRB/NCMR activities, and corrective actions using 8D, RCCA, 5 Why, Fishbone, and DOE methodologies.
• Monitor quality metrics, analyze trends, and implement continuous improvement initiatives to support safe and successful product launches.

What We’re Looking For

Education

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

Experience

• Minimum 3–5 years of Quality Engineering experience in a regulated manufacturing environment; Medical Device industry experience is highly preferred.
• Hands‑on experience in NPI, process validation (IQ/OQ/PQ), TMV, MSA, and qualification of products, processes, equipment, and suppliers.
• Strong knowledge of medical device quality systems, risk management, regulatory compliance, and customer audits.
• Proven ability to collaborate with cross‑functional teams; supervisory or mentoring experience is a plus.

Technical & Leadership Skills

• Working knowledge of ISO 13485, ISO 14971, GMP, SPC, MSA, GR&R, FMEA, Control Plans, Sampling Plans, and process capability analysis (Cp/Cpk, Pp/Ppk).
• Proficient in quality and problem‑solving tools such as 8D, RCCA, 5 Why, Fishbone, DOE, Lean Manufacturing, Six Sigma, and Minitab.
• Strong analytical, communication, presentation, and stakeholder management skills, with a focus on quality, compliance, and patient safety.