Senior Manufacturing & Quality Engineer

C16 Cochlear Malaysia SDN BHD. (Malaysia); Kuala Lumpur; On-site; MYR 120,000 - 180,000; Full time

Job summary

Cochlear Malaysia provides shared services to support Cochlear’s global operations, including manufacturing and repair support in a GMP environment. The role focuses on resolving yield, quality, and throughput issues while driving continuous improvement and NPI transitions.

The ideal candidate brings 5+ years in GMP manufacturing, strong DOE and validation experience, and proven project management, mentoring, and cross-functional collaboration skills in English.

Qualifications

• Minimum 5 years of relevant experience in a GMP manufacturing environment.
• Experience with Design of Experiments (DOE), validation protocols IQ/OQ/PQ, and process validation.
• Strong knowledge of risk tools including DFMEA and PFMEA, and Change Management exposure.
• Excellent written and verbal English communication skills.

Responsibilities

• Act as the first point of contact for Manufacturing and Repair teams regarding yield, quality, and throughput-related issues.
• Provide technical solutions to identified manufacturing and repair challenges.
• Support NPI activities and ensure smooth transition of new products into production.
• Analyse and resolve complex Manufacturing, Quality, and Compliance issues, including CAPAs, non-conformances, and audit observations.
• Ensure NCRs, CAPAs, Concessions, and Change Notes are processed and completed within timelines.
• Identify process improvement opportunities and develop implementation plans while mentoring engineers and technicians.
• Apply structured problem-solving methodologies to analyse failures and implement solutions to improve yield and quality.
• Collaborate with cross-functional teams including Warehouse, Supply Chain, Procurement, and NPI to resolve manufacturing challenges.
• Review and improve product, process, equipment designs, work instructions, and safety requirements to meet objectives.

Skills

Troubleshooting

Continuous improvement

DOE

Process validation

Root cause analysis

Project management

Mentoring engineers

Cross-functional collaboration

Education

Bachelor’s degree in Electrical Engineering

GMP/QMS experience

Tools

Oracle

Job description

Cochlear Malaysia provides shared services to support Cochlear’s global operations, including manufacturing and repair support in a GMP environment. The role focuses on resolving yield, quality, and throughput issues while driving continuous improvement and NPI transitions.

The ideal candidate brings 5+ years in GMP manufacturing, strong DOE and validation experience, and proven project management, mentoring, and cross-functional collaboration skills in English.