Senior Quality System Specialist

Cochlear Limited; Kuala Lumpur; On-site; MYR 180,000 - 260,000; Full time

Benefits offered by this job

Competitive compensation

Global exposure

Job summary

Cochlear Limited in Kuala Lumpur seeks a Senior Quality System Specialist to strengthen our QMS across global operations, ensuring regulatory compliance and effective CAPA/NCR resolution.

You will lead audits, drive data-driven improvements, and partner with stakeholders to implement process changes and training, supporting readiness for external regulatory reviews.

Qualifications

• Bachelor’s degree in Biomedical Engineering, Manufacturing Engineering, or a related field.
• 4–7 years in medical device quality, regulatory compliance, or a similar setting.
• Strong knowledge of QMS in regulated industries and standards.
• Experience with CAPA, NCR, root-cause analysis, and audits.

Responsibilities

• Monitor and improve the Quality Management System (QMS) across global operations.
• Lead CAPA/NCR processes with data-driven decision making.
• Support audits and regulatory readiness, including MDSAP, ISO 13485.
• Coordinate cross-functional teams for governance, training, and process changes.

Skills

CAPA

NCR

Root cause analysis

Internal audits

QMS

Data literacy

Stakeholder facilitation

Project management

Education

Bachelor's degree in Biomedical Engineering

Job description

## Senior Quality System SpecialistApply: Kuala Lumpur: Full time: Posted Today: End Date: October 31, 2026 (30 days left to apply): R-624160Change 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 4-7 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.