Change people’s lives and love what you do! Cochlear develops world-leading medical devices that help people hear. As a top 100 medical device company and market-leader in implantable hearing devices, more people choose a Cochlear-branded cochlear implant system than any other. Our employees tell us that the number one reason they enjoy working for Cochlear is the opportunity to make a difference to people’s lives.
About the Role
We’re hiring a Senior Quality System Specialist to strengthen and continuously improve our Quality Management System (QMS) across global operations. You’ll ensure compliance with international standards, lead internal audits, drive data‑led CAPA/NCR resolution, and prepare the organization for successful external regulatory audits. This role suits a quality professional passionate about compliance, problem-solving, and continuous improvement in a regulated environment.
Key Responsibilities
1) Quality Management System (QMS) – Governance & Improvement
Monitor CLTD QMS performance through defined quality objectives, track progress, and escalate issues where needed.
Maintain a process to capture common root causes across multiple processes; propose targeted quality objectives and improvement plans.
Conduct gap assessments against new/revised standards/regulations to ensure ongoing compliance.
Run process governance forums to maintain compliance, efficiency, and best practice across the Quality System.
Support and sustain a continuous improvement methodology, aligned with Global Quality.
Partner with business stakeholders on audits, document & process change management, and training design/delivery.
Project manage quality improvement initiatives, coordinating cross-functional teams to deliver strategic objectives across domestic and global functions.
2) Issue Management (CAPA & NCR)
Support CAPA/NCR processes to drive timely and effective resolution of product and system issues.
Train and coach CAPA/NCR owners to make data-driven decisions using robust problem-solving tools.
Provide technical evaluation throughout all stages: problem definition, root cause analysis, implementation, and effectiveness verification.
Facilitate Issue Management Review Boards, ensuring management oversight and decisive actions.
Analyse and monitor issue management metrics to assess program effectiveness.
3) Enact, Measure & Improve QMS
Establish and implement core QMS processes: change management, document control, standards management, and training.
Monitor QMS health via KPIs and metrics; identify non‑compliance and opportunities for improvement.
Consolidate learnings from QMS activities to recommend enhancements and standardize best practices.
Participate in all CI stages: gap analysis, user requirements, process development, testing, and user training.
Prepare quality information for monthly metric reporting, product insights, and management review.
Proactively recommend improvements across operations based on data analysis.
4) Audit Support & Regulatory Compliance
Support regulatory and tender audits at CLTD and other global locations.
Contribute to MDSAP readiness and execution.
Participate in internal and external audits to ensure the QMS is continuously reviewed and improved.
Team Role & Safety
Follow relevant quality procedures and participate in continuous improvement initiatives.
Undertake audit responsibilities when trained.
Work safely and report hazards, incidents, or injuries as required.
What You’ll Bring
Graduated in Bachelor’s Degree of Biomedical Engineering, Mechanical Engineering, Electrical/Electronic Engineering (if devices involve electronics), Pharmaceutical Science (for regulated environments), Manufacturing / Production Engineering or anything relevant.
Minimum years’ experience of 5-7 years of experience within medical device industry or relevant industry would be fairly considered.
Strong experience with QMS in regulated industries (medical devices preferred).
Hands-on expertise in CAPA, NCR, root cause analysis, internal audits, and continuous improvement.
Familiarity with international standards and frameworks (e.g., ISO 13485, MDSAP, FDA 21 CFR 820, EU MDR; knowledge of Malaysian MDA guidelines advantageous).
Proven ability to interpret standards, conduct gap assessments, and implement governance frameworks.
Data literacy: confident with KPI tracking, metric analysis, and management reporting.
Excellent communication and stakeholder facilitation skills; able to lead training and process governance forums.
Project management experience across cross-functional teams (PMP nice to have).
What We Offer
Be part of a global, mission-driven medical technology environment.
A collaborative KL-based team with exposure to global stakeholders.
Competitive compensation and benefits; professional development opportunities.
Meaningful impact through audit readiness and system excellence.
Ready to make an impact in a global medical technology leader? Apply now and be part of our CMY team!
Cochlear Malaysia provides shared services to support Cochlear’s global operations. The growing team of professionals in Malaysia provides critical support in areas such as IT infrastructure and applications, development and testing, business intelligence development and support, procurement, customer service, service and repairs and returned device analysis engineering.
If you feel that you have the skills and experience to be successful in this role and take on new challenges to build your career with Cochlear, please start your application by clicking the apply button below.
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Top Skills
What We Do
Hear now. And always
As the global leader in implantable hearing solutions, at Cochlear (ASX: COH) we are committed to our mission to help people hear and be heard. Our story started more than four decades ago when Professor Graeme Clark pioneered the world's first multi-channel cochlear implant and created an entirely new treatment for hearing loss.
Since our formation in 1981, we continue Professor Clark’s work to help people with moderate to profound hearing loss experience a life full of hearing.
We have provided more than 650,000 implantable devices. Each recipient helps form a global community of millions, through families, friends, colleagues, teachers and more. And they’re not just connected to their own community — each shares a link with each other and to Professor Clark’s childhood desire to help people hear.
We aim to give people the best lifelong hearing experience and access to innovative future technologies. We understand the privilege of connecting people to a life lived with hearing. And we listen, respond and move with the times – to continue to bring hearing within reach of all those who need it.
That's how we live our mission every day. Our global workforce of more than 4,000 people shares a collective determination to give more people the opportunity to enjoy a life of hearing.
Cochlear’s global headquarters are on the campus of Macquarie University in Sydney, Australia with regional headquarters in Asia Pacific, Europe and the Americas. Through our offices in over 180 countries we help people of all ages to hear.
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