Quality Engineer: Medical Devices & Regulatory Compliance

Cochlear Limited; Kuala Lumpur; Vor Ort; MYR 60.000 - 120.000; Vollzeit

Zusammenfassung

Cochlear Malaysia seeks a motivated and detail‑oriented Quality Engineer (KL) to support regulatory compliance and manufacturing quality for Class III Active Implantable Medical Devices. You will partner with Manufacturing, Engineering and cross‑functional stakeholders to ensure our QMS and products meet global regulatory, customer and business requirements.

This role suits a quality professional who enjoys problem‑solving and continuous improvement in a highly regulated environment.

Qualifikationen

• Bachelor’s degree in Engineering or Science or equivalent.
• 2–5 years in Quality or Manufacturing Operations in regulated medical devices.
• Hands-on experience with Non-Conformance, Concession, CAPA, and product acceptance.
• Strong data analysis, metrics, and reporting skills.
• Knowledge of ISO 9001, ISO 13485, FDA QSR; MDSAP and EU MDR preferred.
• Internal auditing experience preferred.

Aufgaben

• Ensure regulatory compliance across QMS and products by guiding stakeholders.
• Investigate and apply corrective actions for Class III devices.
• Identify and implement improvements to maintain compliant manufacturing.
• Support NCR, Concession and CAPA processes with cross-functional teams.

Kenntnisse

Quality tools

Data analysis

Metrics reporting

CAPA handling

Ausbildung

Bachelor's degree in Engineering or Science

Jobbeschreibung

Cochlear Malaysia seeks a motivated and detail‑oriented Quality Engineer (KL) to support regulatory compliance and manufacturing quality for Class III Active Implantable Medical Devices. You will partner with Manufacturing, Engineering and cross‑functional stakeholders to ensure our QMS and products meet global regulatory, customer and business requirements.

This role suits a quality professional who enjoys problem‑solving and continuous improvement in a highly regulated environment.