Post Market Quality Specialist

Cochlear; Kuala Lumpur; Hybrid; MYR 180,000 - 240,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Cochlear Malaysia is seeking a Post Market Quality Specialist to ensure regulatory PMS/PMCF reporting across markets and support continuous improvement. The role sits in Kuala Lumpur with hybrid work options.

The successful candidate will manage PMS reporting schedules, coordinate with cross-functional teams, and contribute to system improvements. Requires a degree and 3+ years in data management or post-market surveillance, with strong Excel and BI tool experience.

Qualifications

• Bachelor's degree in any relevant field.
• Minimum 3 years of experience in data management, BI analysis, or post-market surveillance.
• Strong numerical and analytical skills with proven reporting ability.
• Proactive mindset with curiosity to identify trends and insights.

Responsibilities

• Collect and analyse data to complete PMS/PMCF reports.
• Check and correct data errors in systems and processes.
• Collaborate with functions to meet global PMS/PMCF requirements.
• Coordinate submission of reports to regulatory agencies in the required format.
• Maintain PMS/PMCF reporting schedules and ensure on-time delivery.

Skills

Data analysis

Analytical mindset

Communication

Problem solving

Attention to detail

English and Mandarin

Education

Bachelor's degree

Tools

Tableau

OBIEE

MS Excel

Job description

The Opportunity

Cochlear is hiring for an enthusiastic Post Market Quality Specialist who will ensure Cochlear meets the regulatory reporting requirements on post market surveillance in all jurisdictions where Cochlear products are marketed.

The ideal candidate will follow relevant quality procedures to deliver quality products and services and identify and support the implementation of continuous improvement. As well as contribute ideas on systems and process methods to improve deliverables. This role also carries the responsibility for the generation and maintenance of post market surveillance reporting schedules.

This is a full-time, permanent position based at our Kuala Lumpur office, with hybrid work options available.

Accountabilities

Post Market Surveillance Reporting

• Collect and Analyse product data and feedback to complete PMS/PMCF reports according to plans, and where required by regulatory business needs.
• Check and correct errors and problems that may not be immediately evident in the data, systems, or processes.
• Collaborate with other business functions to obtain relevant information and fulfil PMS/PMCF reporting requirements to global standards.
• Coordinate the submission of completed reports to regulatory agencies in the required format

PMS Reporting Schedule Maintenance and Communication

• Coordinate with relevant functions to create and maintain PMS/PMCF reporting schedules that provide good alignment among different projects and jurisdiction requirements, ensure reporting efficiency and on-time delivery
• Support and maintain internal communications, intranet page or other platform/s, ensuring current and accurate information on product reports are readily available to the business.
• Communicate product monitoring status updates as required

Continuous Improvement

• Identify process improvement opportunities, proactively engage in and work collaboratively with stakeholders on its development and implementation.
• Identify and develop enhancements to systems that increase efficiencies through automation

Key Incumbent Requirements

• Minimum Degree in any relevant field.
• 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.
• Proactive mindset demonstrating curiosity and creativity to identify trends and opportunities in data, translating findings into meaningful insights that drive operational excellence.
• Advanced proficiency in MS Excel and experience with business intelligence and visualization tools such as Tableau and OBIEE (Oracle Business Intelligence Enterprise Edition) is preferred.
• Excellent written and verbal communication skills, with the ability to present data and insights to key stakeholders. Strong command of English, including the ability to understand and interpret communications from colleagues for whom English is a second language. Proficiency in both spoken and written Mandarin is required to support effective communication and collaboration with stakeholders in China.
• High attention to detail and accuracy in handling data is critical for this role.
• Ability to think analytically and problem-solve with a continuous improvement mindset.
• Experience in the medical device industry, familiarity with clinical and/or medical terminology, and experience dealing with notified bodies and regulatory authorities are advantageous but not mandatory.

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.