Senior Quality System Specialist

C16 Cochlear Malaysia SDN BHD. (Malaysia); Kuala Lumpur; On-site; MYR 110,000 - 170,000; Full time

Benefits offered by this job

Competitive compensation

Professional development

Audit readiness & system excellence

Job summary

Cochlear Malaysia SDN BHD. is seeking a Senior Quality System Specialist to strengthen and improve our global QMS across operations. You will drive CAPA/NCR resolution, lead internal audits, and prepare the organization for external regulatory audits in a regulated medical device environment.

Qualified candidates have 4–7 years in medical devices, strong QMS experience, and expertise in problem-solving, data analytics, and cross‑functional collaboration to sustain continuous improvement.

Qualifications

• Bachelor’s Degree in Biomedical Engineering or related engineering/science field for regulated environments.
• Minimum 4–7 years in medical devices or a regulated industry.
• Strong experience with QMS in regulated industries (medical devices preferred).
• Hands‑on expertise in CAPA, NCR, root cause analysis, internal audits, and CI.

Responsibilities

• Governance & improvement of the Quality Management System; monitor performance against quality objectives.
• Drive CAPA/NCR processes with data-driven decision making and root cause analysis.
• Establish and maintain core QMS processes: change control, document management, standards management, training.
• Support regulatory audits and readiness; participate in internal and external audits and CI initiatives.

Skills

CAPA

NCR

Root cause analysis

Internal audits

Continuous improvement

KPI tracking

Data literacy

Education

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 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.

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.

We help people of all ages to lead full and active lives. We help people hear and be heard. We empower people to connect with others and live a full life. We help transform the way people understand and treat hearing loss. We innovate and bring to market a range of implantable hearing solutions that deliver a lifetime of hearing outcomes.