Senior Quality Engineer: Regulatory & QMS Excellence

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

Job summary

Cochlear Malaysia Sdn Bhd is seeking a Senior Quality Engineer to ensure regulatory compliance across the Quality Management System and products by partnering with stakeholders. You will provide guidance and training to meet FDA 21 CFR Part 820 and ISO 13485, and support EU MDR and MDSAP compliance.

The role supports Production and Engineering in identifying and addressing quality issues, implements improvements, and mentors teams on QMS standards while coordinating internal and external audits

Qualifications

• Demonstrated comprehensive understanding of complex regulatory frameworks, including ISO 9001, ISO 13485, FDA QSR (21 CFR Part 820), MDSAP, and EUMDR, with proven ability to effectively apply these standards in practical contexts.
• Strong capability in analyzing processes and issues to identify gaps or risks; proficient in NCRs, risk-based methodologies, and quality tools such as FMEA, RCA, and SPC.
• Skilled in developing, reviewing, and maintaining high-quality procedural and technical documentation.

Responsibilities

• Ensure regulatory compliance across the QMS and products by partnering with stakeholders, providing guidance and training to meet FDA 21 CFR Part 820 and EN ISO 13485 (and related standards), EU MDR, MDSAP.
• Assist in identifying, evaluating, containing, investigating and applying corrective actions for Class 3 Active Implantable Medical Devices across Manufacturing and Logistics.
• Support the NCR process with regular problem-solving meetings to provide direction and support for the stakeholder; assist concessions as needed.
• Support First Time Quality, Fast Response and Morning Market meetings.
• Conduct regular internal audits and manage external audits.
• Review QMS documents for proposed changes or product-related changes.
• Identify, initiate and implement improvements to QMS processes.
• Produce KPI metrics and data analysis on NCRs; ensure timely delivery of periodic reports.
• Collaborate with Process Engineering and Validation teams to design Manufacturing Quality Plans (MQP) and support MQP implementation.

Skills

Regulatory frameworks: ISO 9001/13485,

FDA QSR 21 CFR Part 820

MDSAP

EUMDR

NCR / CAPA management

FMEA & root cause analysis

Statistical process control

Documentation & SOP writing

Stakeholder management

Auditing (internal/external)

Education

Bachelor's degree in Electrical / Mechanical Engineering or equivalent

Tools

MES

ERP

QMS platforms

MS Excel

Power BI

Job description

Cochlear Malaysia Sdn Bhd is seeking a Senior Quality Engineer to ensure regulatory compliance across the Quality Management System and products by partnering with stakeholders. You will provide guidance and training to meet FDA 21 CFR Part 820 and ISO 13485, and support EU MDR and MDSAP compliance.

The role supports Production and Engineering in identifying and addressing quality issues, implements improvements, and mentors teams on QMS standards while coordinating internal and external audits