This Senior Quality Engineer position at Cochlear offers a unique opportunity to ensure the quality and regulatory compliance of life-changing hearing implant technologies. As the global leader in implantable hearing solutions, Cochlear delivers medical devices that restore hearing to thousands worldwide. In this critical role, you'll be the guardian of quality standards for Class 3 Active Implantable Medical Devices, directly impacting patients who depend on Cochlear's technologies for life-changing hearing experiences.
Key Responsibilities:
- Ensure regulatory compliance across the Quality Management System for FDA 21 CFR Part 820, ISO 13485, EU MDR, and MDSAP requirements
- Lead quality initiatives for Class 3 Active Implantable Medical Devices through manufacturing and logistics operations
- Manage Non-Conformance Report (NCR) processes and conduct root cause analysis for quality issues
- Perform internal audits and support external regulatory audits with global authorities
- Develop and implement Manufacturing Quality Plans in partnership with Engineering and Validation teams
- Drive continuous improvement of QMS processes and provide quality metrics for executive reporting
Required Qualifications & Experience:
- Bachelor's degree in Electrical/Mechanical Engineering or equivalent
- 6+ years in Quality or Manufacturing within Medical Device industry (Class 3 device experience preferred)
- 4+ years in Senior Quality Engineer role with demonstrated leadership responsibilities
- Comprehensive expertise in FDA QSR, ISO 13485, MDSAP, and EU MDR regulations
- Proven experience with NCR, CAPA, auditing, and quality management systems
Critical Technical Competencies:
- Advanced knowledge of risk-based methodologies (FMEA, root cause analysis, statistical process control)
- Experience with Manufacturing Quality Planning and design transfer processes
- Proficiency in quality tools and data analysis (Microsoft Excel, Power BI, MES/ERP systems)
- Strong documentation skills for procedural and technical content
- Internal auditor certification (ISO 13485 or ISO 9001) preferred
Why This Role Stands Out:
This isn't just another quality engineering position - it's a chance to ensure the reliability of medical devices that literally change how people experience the world. You'll be working with cutting-edge implantable technology while collaborating with global teams across Cochlear's international operations. The role offers exceptional visibility into the entire product lifecycle of Class 3 medical devices, from manufacturing through to patient delivery.
Impact & Professional Growth:
- Direct contribution to medical devices that restore hearing to patients globally
- Exposure to complex regulatory frameworks across multiple international markets
- Leadership development through mentoring and cross-functional collaboration
- Career advancement opportunities within Cochlear's global quality organization
- Work with state-of-the-art quality systems and manufacturing technologies
About Cochlear's Global Mission:
Cochlear is the global leader in implantable hearing solutions, dedicated to helping people with moderate to profound hearing loss experience a life full of hearing. As a top 100 medical device company, Cochlear employs thousands of professionals worldwide who share the mission of connecting people with life-changing hearing technology. The Malaysia shared services center provides critical support for Cochlear's global operations, offering professionals exceptional career growth in the medical device industry.
Work Environment & Culture:
- Collaborative, mission-driven culture focused on making a difference in patients' lives
- Professional development opportunities in a global medical device leader
- Inclusive workplace that values technical excellence and innovation
- Supportive team environment with opportunities for independent contribution
- Comprehensive benefits and competitive compensation package
