Specialist, Quality Management (Complaint Management)

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 customer complaints from the complainant and work with the relevant Legal Manufacturer or outsourced service suppliers for the investigation and closure of complaints.

• Manage complaint logs shared between Legal Manufacturer and Sysmex in the designated SharePoint to ensure timely updates of complaint progress.

• Coordinate with Clinical Specialist Representatives (CSR) on the 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 Regulatory Affairs on vigilance reporting to respective local authorities.

• Ensure affected batches or serial numbers of units are quarantined physically and in the system via respective affiliates and/or Warehouse.

• Provide progress updates of FCA to Legal Manufacturer.

• Coordinate and follow up with respective affiliates or stakeholders (Warehouse/CC Team) to dispose/destruct recalled units.

Risk Management

• Maintain the effectiveness of risks associated with complaint management and post-market activities for medical devices in the Enterprise Risk Register.

Quality & Environmental Objectives Monitoring

• Support the Quality Management Representative in monitoring, analyzing, and reporting 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 at 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 environmental intelligence on a monthly basis.

• Support QMR/QM Manager in crafting policies, frameworks, or procedures that incorporate Environmental & WSH regulations/requirements.

ECO Track

• Ensure ECO Track data is uploaded and tracked on a monthly basis within the ECO Track system.

Audit Support (Internal and External)

• Support planning, execution, and follow-up of internal audits at the discretion of the 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 audit findings related to Complaint Management & Post Market Activities for RAS, Quality Environmental Objectives, EMS and Environmental Intelligence are addressed through effective corrective actions and continuous improvement.

Regional Quality Meeting

• Support the Quality Management Representative and QM Manager in coordinating and managing the Regional Quality Monthly Meeting by collating data from Affiliates and preparing presentation materials.

Job Requirements

• Minimum 2 years' experience in a Quality Assurance role within the Medical Devices industry.

• Certified Internal Auditor for ISO 13485 / ISO 9001 and/or ISO 14001.

• Knowledge of:

- ISO 13485

- ISO 9001 Quality Management Systems (QMS)

- ISO 27001

- ISO 14001 Environmental Management Systems (EMS)

- Workplace Safety and Health (WSH)

• Proficient in Microsoft Office.

• Previous experience in Complaint Handling and Post-Marketing Activities.

• Experience in Data Trending and Analysis.