Cochlear is a global leader in implantable hearing solutions dedicated to helping people with moderate to profound hearing loss experience life full of hearing
Job Summary
Cochlear is a global leader in implantable hearing solutions dedicated to helping people with moderate to profound hearing loss experience life full of hearing.
The Senior Quality Engineer ensures regulatory compliance across the Quality Management System by partnering with stakeholders to meet FDA and ISO standards.
This role involves investigating quality issues for Class 3 Active Implantable Medical Devices and driving corrective actions through robust root cause analysis.
Matching Summary
Cochlear is a global leader in implantable hearing solutions dedicated to helping people with moderate to profound hearing loss experience life full of hearing.
Skills & Requirements
Must-have
FDA 21 CFR Part 820 compliance
ISO 13485 regulatory standards
Class 3 Active Implantable Medical Devices
Non-Conformance Report management
Internal and External audit experience
Root cause analysis and FMEA
Manufacturing Quality Planning
Nice-to-have
MDSAP and EU MDR knowledge
Power BI data analysis skills
MES and ERP platform proficiency
Certified Internal Auditor status
Stakeholder mentoring capabilities
First Time Quality support
Collaborative cross-functional teamwork
Key Requirements
Minimum Bachelor's degree in Electrical or Mechanical Engineering
At least 6 years experience in regulated Medical Device industry
Minimum 4 years experience as Senior Quality Engineer
Hands-on experience managing NCRs and CAPA processes
Direct experience with Class 3 device manufacturing environments