Senior Post Market Quality Specialist (KL)

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.

Cochlear’s mission is to help people hear and be heard. As the global leader in implantable hearing solutions, Cochlear is dedicated to helping people with moderate to profound hearing loss experience a life full of hearing. We aim to give people the best lifelong hearing experience and access to innovative future technologies. We collaborate with the industry’s best clinical, research and support networks. That’s why more people choose Cochlear than any other hearing implant company. Learn and grow with us as we tackle the most complex challenges in helping more people to hear and experience life’s opportunities.

The Opportunity

Cochlear is hiring for an enthusiastic Senior Post Market Quality Specialist (KL) and this role is responsible for generating and maintaining Post Market Surveillance (PMS) reports and managing the flow of data into the Risk Management Process. This includes coordinating reporting requirements specific to the European Medical Device Regulations (EU MDR).

Key Responsibilities;

1. 1. Post Market Surveillance Reports and Analysis
2. 2. Product Monitoring and Communication

• Develop PMS and Post Market Clinical Follow Up (PMCF) plans for new products and review/update plans for existing products as required.
• Collect and analyze product data and feedback to complete PMS/PMCF reports in accordance with plans and regulatory business needs.
• Identify and correct errors or issues in data, systems, or processes that may not be immediately obvious.
• Collaborate with Quality, Clinical, and Regulatory teams to gather relevant PMS/PMCF information and ensure reports meet global standards.
• Coordinate the submission of completed reports to regulatory agencies, including Periodic Safety Update Reports (PSURs) in Eudamed.
• Analyze and communicate report outcomes, highlighting potential issues to key stakeholders.
• Collect and analyze product quality data, communicating trends through Corrective and Preventive Action (CAPA), Field Issue Trending (FIT), and Post Market Review (PMR) meetings.
• Detect and correct errors in data, systems, or processes as needed.
• Maintain and support internal communications platforms, such as intranet pages, ensuring up-to-date and accurate product reporting information is available.
• Provide regular product monitoring status updates.
• Prepare trend and analysis reports as required

3. Continuous Improvement

• Identify opportunities for process improvements and work collaboratively with stakeholders to develop and implement enhancements.
• Develop system enhancements aimed at increasing efficiency through automation.

Position Specific Skills and Challenges

• Ability to interpret and apply EU MDR and global post-market surveillance requirements in a fast-paced, regulated environment.
• Strong skills in data collection, analysis and reporting to identify trends, ensure data accuracy, and support risk management.
• Work effectively with Regulatory, Quality and Clinical teams to gather insights and ensure timely reporting.
• Advanced Excel and business intelligence tool skills (e.g., Tableau, OBIEE), plus experience with QMS software (e.g., Trackwise).

Key Requirements;

• Bachelor’s degree in engineering, science, or a related discipline.
• Minimum 5 years’ experience in data management, business intelligence analysis, or post-market surveillance, preferably within the medical device industry.
• Experience working with notified bodies and regulatory authorities with a strong understanding of clinical and/or medical terminology.
• Proficiency with business intelligence and visualization tools such as Tableau or OBIEE, and Quality Management System (QMS) software like Trackwise.
• Strong numerical and analytical skills, with proven experience in data analytics, insights generation, and delivering high-quality reports.
• Proactive mindset with curiosity and creativity to identify trends and translate data into actionable operational insights.
• Excellent written and verbal communication skills, including experience presenting complex data and insights clearly to stakeholders and managing multiple priorities.
• Highly adaptable and flexible, with advanced MS Excel skills and the ability to quickly learn new tools and processes.

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.

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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