Senior Quality System Specialist

Cochlear Malaysia Sdn Bhd; Kuala Lumpur; On-site; MYR 80,000 - 105,000; Full time

Job summary

A medical technology leader in Kuala Lumpur is looking for a Senior Quality System Specialist to enhance their Quality Management System. The successful candidate will ensure compliance with international standards and manage CAPA/NCR processes. Candidates should possess a Bachelor's degree and have 5-7 years of experience in the medical device industry. This role offers competitive compensation and a chance to make a meaningful impact in a global organization.

Benefits

Competitive compensation

Professional development opportunities

Qualifications

• Minimum 5-7 years of experience in the medical device industry or similar.
• Strong experience in regulated industries and QMS.
• Hands-on expertise in CAPA, NCR, and internal audits.

Responsibilities

• Monitor QMS performance and track quality objectives.
• Train CAPA/NCR owners in data-driven decision making.
• Participate in internal and external audits for continuous improvement.

Skills

Quality Management System expertise

CAPA/NCR processes

Root cause analysis

Data analysis

Excellent communication

Education

Bachelor’s Degree in Biomedical Engineering, Mechanical Engineering, or related field

Tools

ISO 13485

MDSAP

Job description

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. 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 and 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 standardise 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 5‑7 years of experience within medical device industry or relevant industry.
• 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 (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.