Senior QA Engineer, Regulatory Compliance

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

Job summary

Cochlear Malaysia SDN BHD. (Malaysia) seeks a Senior Quality Engineer to ensure regulatory compliance across QMS and implanted devices. You will partner with Production and Engineering to maintain FDA 21 CFR Part820, ISO13485, and related standards while mentoring stakeholders.

Role includes driving CAPAs, NCRs, audits, and process improvements; you will work with cross-functional teams to ensure timely quality deliverables and robust documentation.

Qualifications

• Comprehensive understanding of ISO9001, ISO13485, FDA QSR (21CFR Part820), MDSAP, and EUMDR.
• Experience applying these standards in practical, real-world contexts.
• Strong in identifying gaps or risks in processes and implementing corrective actions.
• Ability to write precise procedural and technical documentation.
• Experience managing NCRs, CAPA, concessions and product acceptance processes.

Responsibilities

• Ensure regulatory compliance across the QMS and products; guide stakeholders to meet standards.
• Identify, evaluate, contain, investigate and apply corrective actions for Class3 devices.
• Support NCR processes with problem-solving meetings and stakeholder direction.
• Assist in concessions within relevant areas and support MQP implementation.
• Facilitate First Time Quality, Fast Response and Morning Market meetings.
• Conduct internal audits and support external audits.
• Review QMS documents for changes and product-related updates.
• Design Manufacturing Quality Plans in collaboration with Process Engineering and Validation teams.
• Produce KPIs and data analysis on NCRs and QMS performance.

Skills

Regulatory knowledge

Auditing

Risk management

Documentation

Stakeholder management

Quality improvement

Education

Bachelor’s degree in Electrical / Mechanical Engineering

Tools

Excel

Power BI

MES

ERP

QMS platforms

Job description

Cochlear Malaysia SDN BHD. (Malaysia) seeks a Senior Quality Engineer to ensure regulatory compliance across QMS and implanted devices. You will partner with Production and Engineering to maintain FDA 21 CFR Part820, ISO13485, and related standards while mentoring stakeholders.

Role includes driving CAPAs, NCRs, audits, and process improvements; you will work with cross-functional teams to ensure timely quality deliverables and robust documentation.