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Post Market Quality Specialist

Post Market Quality Specialist

CochlearKuala Lumpur, Kuala Lumpur, Malaysia
23 jam yang lalu
Penerangan pekerjaan

Cochlear Malaysia – Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia

Overview

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 collaborate with clinical, research and support networks to tackle the most complex challenges in helping more people hear and experience life’s opportunities.

The Opportunity : Cochlear is hiring an enthusiastic Post Market Quality Specialist who will ensure Cochlear meets regulatory reporting requirements on post market surveillance in all jurisdictions where Cochlear products are marketed. The ideal candidate will follow quality procedures to deliver quality products and services, identify and support continuous improvement, and 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 align different projects and jurisdiction requirements, ensure reporting efficiency and on-time delivery

  • Support and maintain internal communications, intranet pages or other platforms with current and accurate information on product reports
  • Communicate product monitoring status updates as required
  • Identify process improvement opportunities and work with stakeholders on development and implementation
  • Identify and develop enhancements to systems that increase efficiencies through automation
  • Qualifications and 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 experience in data analysis, insights reporting, and delivering high-quality reports
  • Proactive mindset with curiosity and creativity to identify trends and translate findings into insights that drive operational excellence
  • Advanced proficiency in MS Excel; experience with BI and visualization tools (Tableau, OBIEE) is preferred
  • Excellent written and verbal communication skills in English; ability to comprehend communications from staff for whom English is a second language
  • High attention to detail and accuracy in handling data
  • Analytical thinker with problem-solving skills and a continuous improvement mindset
  • Experience in the medical device industry, familiarity with clinical / 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. If you feel you have the skills and experience to be successful in this role, please start your application by clicking the apply button below.

    EEO Statement : Cochlear is an equal opportunity employer and supports a diverse workforce. Referrals increase your chances of interviewing at Cochlear.

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    Buat amaran kerja untuk carian ini

    Quality Specialist • Kuala Lumpur, Kuala Lumpur, Malaysia