Key Job Purpose
The Quality Management (QM) Specialist is responsible for ensuring that the organization adheres to all regulatory and quality standards by effectively managing critical quality systems, including Complaint Management & Post Market Activities for Robotic Assisted
Surgery (RAS) business, and overall SAP Quality Performance, KPIs and Data Analysis. The role serves to maintain a high standard of compliance, accuracy, and continuous improvement throughout the organization's quality processes.
The role involves managing the Environmental data within the ECO tracking system, monitoring of Environment regulations and providing support across the region to ensure consistent quality practices and compliance for environmental perspectives. The role will assist in coordinating and managing the Regional Quality Monthly Meeting.
Job Description
Complaint Management
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving product quality issues. Track and monitor the customer complaint from the complainant and work with the relevant legal manufacturer or outsourced service suppliers for the investigation and closure of the complaint.
- Management of complaint log shared between Legal Manufacturerand Sysmex in designated sharepoint to ensure timely update of complaint progress.
- Coordinate with Clinical Specialist Representative (CSR) on availability of defective units on availability of defective units. Coordinate with Supply Chain and Warehouse to arrange shipment of defective units back to the legal manufacturer. Coordinate with Regulatory Affairs on event reportability and timely response to Authorities.
- Analyze complaint data to support ongoing monitoring of device safety and performance.
Post Market Activities
- Execute post-market activities such as field corrective action (FCA) per the notification letter from Legal Manufacturer and follow up with RAs on the vigilance reporting to respective local authorities.
- Ensure affected batches or serial number of units are quarantined physically and in system via respective affiliates and/or Warehouse.
- Provide progress update of FCA to LM.
- Coordinate and follow-up with respective affiliates or stakeholders (warehouse/CC team) to dispose/destruct the recalled units.
Risk Management
- Maintain the effectiveness of risk associated complaint management and post - market activities for medical device in the Enterprise Risk Register.
Quality & Environmental Objectives Monitoring
- Support the Quality Management Representative in monitoring and analyzing the data and reporting of Quality Objectives to achieve departmental objectives and goals for both QMS and EMS.
- Coordinate and follow- up with functional stakeholders on reporting of goals/KPIs on regular intervals.
Environmental System
- Provide expertise and guidance on environmental issues that impact production and quality management, ensuring that all operations comply with EMS or Global ESG Goals.
- Coordinate with relevant stakeholders and consolidate the environmental intelligence in monthly manner.
- Support QMR / QM Manager in crafting the policy, framework or procedures which incorporates Environmental & WSH regulations/requirements.
ECO Track
- Ensure the ECO track data are being uploaded and tracked on a monthly basis to the ECO track system and support.
Audit Support (Internal And External)
- Support in planning, execution, and follow-up of internal audits per discretion of QM Manager/QMR, ensuring compliance with regulatory standards and company policies.
- Support external audits by coordinating audit activities, preparing documentation, and ensuring audit readiness.
- Ensure that audit findings related to Complaint Management & Post Market for RAS, Quality Environmental Objectives, EMS and Environmental Intelligence are addressed through effective corrective actions and continuous improvement.
Regional Quality Meeting
- Support Quality Management Representative and QM Manager in coordinating and
- managing the Regional Quality Monthly Meeting, by collating the data from Affiliates and preparing the presentation materials.
Job Requirements
- Minimum 2 years experience in Quality Assurance role in Medical Devices industry
- Certified Internal Auditor for ISO13485 / ISO9001 and/or ISO14001
- ISO 13485 / ISO 9001 QMS / ISO 27001
- ISO 14001 Environmental Management Systems (EMS)
- Workplace Safety and Health (WSH)
- Microsoft Office
- Previous experience in Complaint Handling and Post-Marketing Activities, Data Trending & Analysis
