Quality Engineer - NPI (Medtech)

Knowles Electronics (Philippines) Corporation; Central Visayas; On-site; PHP 550,000 - 900,000; Full time

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, located at Cebu Light Industrial Park, Lapu-Lapu City, Cebu, is seeking 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.

Relocation Assistance Available

Qualified candidates residing outside the Visayas region are welcome to apply. Relocation assistance is available for the selected candidate to support their transition to the role location.

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.