Senior Manufacturing Process Engineer

Cochlear; Kuala Lumpur; On-site; MYR 120,000 - 180,000; Full time

Job summary

Cochlear Malaysia is hiring a Senior Engineer/Engineer Manufacturing Support to provide engineering backing for manufacturing and repair operations. You will tackle day-to-day challenges, drive process improvements, and support cost-saving initiatives while ensuring quality and compliance.

The role requires strong problem-solving, cross‑functional collaboration, and experience with NPI, CAPAs, and change management in a GMP environment.

Qualifications

• Minimum 5 years of relevant experience in GMP manufacturing.
• Experience working within a QMS framework and ISO exposure.
• Experience with Design of Experiments (DOE) and validation protocols (IQ/OQ/PQ).

Responsibilities

• Act as first point of contact for manufacturing and repair teams on yield, quality, and throughput issues.
• Provide technical solutions to manufacturing and repair challenges.
• Support NPI activities and ensure smooth product transitions to production.
• Analyse and resolve Manufacturing, Quality, and Compliance issues including CAPAs and NCRs.
• Ensure NCRs, CAPAs, Concessions, and Change Notes are processed within timelines.
• Identify process improvements and mentor engineers and technicians as needed.
• Apply problem‑solving methods to identify root causes and implement solutions to improve yield and quality.
• Collaborate with Warehouse, Supply Chain, Procurement, and NPI to resolve challenges.
• Review and improve product/process designs, work instructions, and safety requirements.

Skills

Manufacturing support

DOE

CAPA

Quality systems

GMP

Education

Bachelor's in Electrical/Manufacturing Eng

Tools

Oracle

Job description

Cochlear Malaysia is hiring a Senior Engineer/Engineer Manufacturing Support to provide engineering backing for manufacturing and repair operations. You will tackle day-to-day challenges, drive process improvements, and support cost-saving initiatives while ensuring quality and compliance.

The role requires strong problem-solving, cross‑functional collaboration, and experience with NPI, CAPAs, and change management in a GMP environment.