Engineer Quality. Transform Lives with Hearing.
Cochlear is the global leader in implantable hearing solutions. Our mission is to help people hear and be heard. We develop world-leading medical devices that change lives, and more people choose a Cochlear hearing implant system than any other. Our employees tell us the number one reason they love working here is the opportunity to make a real difference.
Join us in our Kuala Lumpur global shared services centre and be part of a team dedicated to quality excellence for life-changing Class III medical devices.
Your Opportunity
We are seeking a motivated Quality Engineer to ensure regulatory compliance and manufacturing quality for our Class III Active Implantable Medical Devices. In this hands-on role, you will partner with Manufacturing, Engineering, and cross-functional teams to uphold our Quality Management System (QMS), resolve non-conformances, and drive continuous improvement. This is an ideal role for a quality professional passionate about problem-solving in a highly regulated, impactful environment.
Your Key Responsibilities
Compliance & Quality System Stewardship:
- Ensure compliance with FDA 21 CFR Part 820, ISO 13485, EU MDR, and MDSAP by providing guidance and training to stakeholders.
- Review QMS documents and product-related changes to maintain regulatory alignment.
- Support internal and external audits, and assist in implementing corrective actions.
Non-Conformance & Corrective Action Management:
- Lead the Non-Conformance Report (NCR) process, facilitating problem-solving meetings and guiding stakeholders through containment, investigation, and corrective action (CAPA).
- Manage Concession implementation within supporting areas.
- Produce key performance metrics and data analysis on NCRs to drive quality improvements.
Manufacturing Quality & Continuous Improvement:
- Partner with Process Engineering to design practical, risk-based Manufacturing Quality Plans (MQP) and support their implementation.
- Identify and implement improvements to ensure compliant products that meet customer and business needs.
- Support First Time Quality, Fast Response, and Morning Market meetings.
- Ensure effective training is delivered for all process changes.
Why You Are The Right Fit
Your Skills & Experience:
- 3-5 years of experience in Quality or Manufacturing within a regulated Medical Device industry; experience with Class III devices is a strong advantage.
- Bachelor's degree in Engineering or Science.
- Direct hands-on experience with Non-Conformance, Concession, and CAPA processes.
- Strong proficiency with quality tools (FMEA, root cause analysis, basic SPC) and data analysis/metrics reporting.
- Practical knowledge of ISO 13485, FDA QSR (21 CFR Part 820); familiarity with MDSAP and EU MDR is advantageous.
- Audit experience; Internal Auditor certification (ISO 13485/9001) is preferred.
- Excellent documentation skills with a passion for accuracy and detail.
- Outstanding communication skills in English (written and oral) are essential.
Your Attributes:
- A collaborative team player with strong stakeholder management and influencing skills.
- Analytical, proactive problem-solver with a focus on continuous improvement.
- Ability to work independently and manage multiple priorities in a dynamic environment.
Why Join Cochlear Malaysia?
- Purpose-Driven Work: Contribute directly to creating medical devices that restore hearing and transform lives globally.
- Global Impact: Be part of Cochlear's international shared services hub, supporting worldwide operations.
- Career Growth: Develop your expertise in a top-tier medical device company with a clear commitment to employee development.
- Inclusive Culture: Join a values-driven organisation where people and quality are paramount.
If you have the skills and passion to ensure the highest quality for life-changing technology, we encourage you to apply.
Ready to build your career with the leader in implantable hearing solutions?
Apply now for the Quality Engineer position in Kuala Lumpur.
#CochlearCareers
Cochlear is proud to be an equal opportunity employer.
