Senior Quality System Specialist

Cochlear; Kuala Lumpur; On-site; MYR 80,000 - 110,000; Full time

Job summary

A leading medical device company in Kuala Lumpur is seeking a Senior Quality System Specialist to enhance their Quality Management System. The role involves ensuring compliance with international standards, conducting internal audits, and driving quality improvements. Applicants should possess 5-7 years experience in the medical device industry, with strong skills in CAPA, NCR, and data analysis. Join a collaborative team making a meaningful impact in global medical technology.

Benefits

Competitive compensation

Professional development opportunities

Collaborative work environment

Qualifications

• Minimum of 5-7 years experience within medical device industry or relevant industry.
• Strong experience with QMS in regulated industries, preferably medical devices.
• Hands-on expertise in CAPA, NCR, root cause analysis, and internal audits.
• Familiarity with international standards like ISO 13485 and FDA guidelines.

Responsibilities

• Ensure compliance with international standards for the Quality Management System.
• Conduct internal audits and lead data-led CAPA/NCR resolution.
• Project manage quality improvement initiatives across functions.
• Support regulatory and internal audits to improve the Quality Management System.

Skills

QMS in regulated industries

CAPA

NCR

root cause analysis

internal audits

continuous improvement

data literacy

excellent communication

project management

Education

Bachelor’s Degree in Biomedical Engineering, Mechanical Engineering, Electrical/Electronic Engineering, Pharmaceutical Science, Manufacturing / Production Engineering

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..

   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.

5. 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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