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Senior Post Market Quality Specialist (KL)
CochlearKuala Lumpur, Kuala Lumpur, Malaysia9 hours ago
Job descriptionCollect and analyze product quality data, communicating trends through CAPA, FIT, and 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. Identify opportunities for process improvements and work collaboratively with stakeholders to develop and implement enhancements. Develop system enhancements aimed at increasing efficiency through automation. 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). 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 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.
Senior Post Market Quality Specialist (KL)
Cochlear Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia
Overview
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
- 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.
Product Monitoring and Communication
Position Specific Skills and Challenges
Key Requirements
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Quality Specialist • Kuala Lumpur, Kuala Lumpur, Malaysia
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