Senior Quality System Specialist

Cochlear Malaysia Sdn Bhd; Kuala Lumpur; On-site; MYR 120,000 - 180,000; Full time

Benefits offered by this job

Professional development opportunities

Competitive compensation

Global exposure

Job summary

Cochlear Malaysia Sdn Bhd in Kuala Lumpur is seeking a Senior Quality System Specialist to strengthen and continuously improve our Quality Management System across global operations. You will ensure compliance with international standards, lead internal audits and drive CAPA/NCR resolution.

This role demands a data-led mindset, robust problem-solving, and the ability to partner with cross-functional teams to support regulatory audits and continuous improvement initiatives.

Qualifications

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Electrical/Electronic Engineering, Pharmaceutical Science, or related.
• 4–7 years in medical device or regulated industry.
• Strong knowledge of QMS in regulated industries (medical devices preferred).

Responsibilities

• Govern QMS governance and drive continuous improvement.
• Lead CAPA/NCR processes and train owners in data-driven decisions.
• Capture and analyse quality metrics for monthly reporting.
• Support regulatory audits and readiness across global locations.
• Coordinate cross-functional quality improvement projects.

Skills

CAPA/NCR

Root cause analysis

Internal audits

Data literacy

Project management

Cross-functional collaboration

Education

Bachelor's degree in Biomedical/Mechanical/Electrical/Electronic Engineering or related

Job description

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 elevate 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.