NPI Quality Lead: MedTech Launch & Compliance

Hammerjack Pty Ltd; Philippines; On-site; PHP 600,000 - 900,000; Full time

Job summary

Hammerjack Pty Ltd is seeking a Quality Engineer - NPI (Medtech) to lead quality activities during New Product Introduction in a highly regulated medical device environment. You will collaborate with Engineering, Manufacturing, Operations, and Supplier Quality to ensure robust processes and successful product launches.

The role requires hands-on experience with IQ/OQ/PQ, TMV, MSA, and supplier qualification, plus a strong knowledge of ISO 13485, ISO 14971, and GMP.

Qualifications

• Bachelor's degree in Electronics, Electrical, or related Engineering.
• 3-5 years of Quality Engineering experience in a regulated manufacturing environment; Medical Device industry experience preferred.
• Hands-on experience in NPI, process validation (IQ/OQ/PQ), TMV, MSA, and qualification of products, processes, equipment, and suppliers.

Responsibilities

• Lead quality activities during NPI and Product Readiness across DVT, PVT, and Mass Trial phases.
• Drive qualification/validation activities (IQ/OQ/PQ), TMV, MSA, and supplier qualification to ensure ISO 13485 compliance and audit readiness.

Skills

NPI quality leadership

Cross-functional collaboration

Quality data analysis

Regulatory awareness

Education

Bachelor's degree in Electronics/Electrical Engineering

Tools

8D problem solving

RCCA

FMEA

Control Plans

Minitab

Job description

Hammerjack Pty Ltd is seeking a Quality Engineer - NPI (Medtech) to lead quality activities during New Product Introduction in a highly regulated medical device environment. You will collaborate with Engineering, Manufacturing, Operations, and Supplier Quality to ensure robust processes and successful product launches.

The role requires hands-on experience with IQ/OQ/PQ, TMV, MSA, and supplier qualification, plus a strong knowledge of ISO 13485, ISO 14971, and GMP.