Post Market Quality Specialist role at Cochlear, KL. Manage global post-market surveillance reporting, data analysis & schedule coordination. 3+ yrs exp in data mgmt/PMS, strong analytics & MS Excel req. Med device exp a plus. #QualityAssurance #PostMarketSurveillance #MedicalDevice #KualaLumpur #CochlearCareers
Ensure Lifelong Hearing Safety: Specialize in Post-Market Quality
Change people’s lives and love what you do. Cochlear is the global leader in implantable hearing solutions. We are dedicated to helping people experience a life full of hearing. Our mission drives everything we do, and our employees cite the opportunity to make a difference as the number one reason they love working here.
The Opportunity
We are hiring an analytical and proactive Post Market Quality Specialist to play a critical role in ensuring Cochlear meets global regulatory reporting requirements for post-market surveillance. You will be responsible for analyzing product data, generating key reports, and maintaining schedules that demonstrate the ongoing safety and performance of our life-changing devices worldwide.
This is a full-time, permanent position based at our Kuala Lumpur office, with hybrid work options available. You will join a global shared services team that provides vital support to Cochlear’s operations.
Your Mission: Guardian of Product Performance & Compliance
You will transform post-market data into actionable insights and regulatory deliverables, ensuring transparency and compliance across all markets.
Key Accountabilities
1. Post Market Surveillance Reporting (Core Focus)
- Collect, analyze, and interpret product performance data and customer feedback to complete Post Market Surveillance (PMS) and Post Market Clinical Follow-up (PMCF) reports.
- Collaborate cross-functionally with Clinical, Regulatory, and Quality teams to gather necessary information and fulfil global reporting requirements.
- Coordinate the submission of finalized reports to regulatory agencies in the correct formats and timelines.
- Perform meticulous data checks to identify and correct errors in systems or processes.
2. PMS Reporting Schedule Maintenance & Communication
- Create and maintain master reporting schedules, aligning multiple projects and jurisdictional requirements to ensure efficiency and on-time delivery.
- Maintain internal communications platforms (e.g., intranet) to ensure accurate, readily available information on product report status for the business.
- Communicate product monitoring updates clearly to relevant stakeholders.
3. Drive Continuous Improvement
- Proactively identify opportunities for process improvement and collaborate on their implementation.
- Identify and help develop system enhancements and automations to increase team efficiency and data accuracy.
Who You Are: The Ideal Candidate
You are a data-driven professional with a keen eye for detail and a passion for ensuring product quality and patient safety through rigorous analysis.
Key Requirements
- Minimum Bachelor’s Degree in a relevant field (Life Sciences, Engineering, Data Analytics, etc.).
- At least 3 years of experience in data management, business intelligence analysis, or post-market surveillance.
- Strong numerical and analytical skills with proven experience in data analysis, insight reporting, and delivering high-quality reports.
- Advanced proficiency in MS Excel; experience with BI/visualization tools like Tableau or OBIEE is preferred.
- Excellent written and verbal English communication skills, with the ability to present data insights to stakeholders and comprehend nuanced written communication.
- High attention to detail and accuracy is critical.
- A proactive, curious mindset with a strong focus on continuous improvement.
What Will Make You Stand Out:
- Experience in the medical device or pharmaceutical industry.
- Familiarity with clinical/medical terminology.
- Experience interacting with notified bodies or regulatory authorities.
Why Build Your Career at Cochlear Malaysia?
Cochlear Malaysia provides essential shared services supporting our global operations. The growing team in Kuala Lumpur is integral in IT, business intelligence, procurement, customer service, and engineering.
1. Impact Through Data
- Your work directly ensures the ongoing safety and performance of medical devices that restore hearing to thousands of people.
- Play a key compliance role in a globally regulated industry.
2. Professional Growth
- Develop deep expertise in global medical device regulations (MDR, FDA requirements) and post-market surveillance.
- Gain exposure to cross-functional global processes and data systems.
3. Valued & Supported
- Enjoy the flexibility of a hybrid work model in a modern office environment.
- Be part of a supportive, mission-driven global community that values your contribution.
Ready to Use Your Analytical Skills to Uphold a Global Standard of Care?
If you have the skills and passion for data-driven quality assurance in a meaningful industry, we want to hear from you.
Start your application by clicking the link below to apply for the Post Market Quality Specialist role in Kuala Lumpur.
