PMS Complaint Handling Specialist

PMS Complaint Handling Specialist

Job Profile Summary:

The PMS Complaint Handling Specialist is responsible for managing and executing CAPA activities related to complaint handling and post market surveillance activities within a regulated environment. This role ensures timely and effective resolution of quality issues by leading root cause investigations, developing robust corrective and preventive actions, and driving continuous improvements. This role will require strong analytical skills, a deep understanding of medical device regulations, and the ability to lead cross-functional teams through complex investigations. This role requires a proactive approach to identifying root causes, implementing sustainable solutions, and driving continuous improvement across the organization.

Job Responsibilities:

• Executes the CAPA process, overseeing investigations into nonconformances, determining root causes, and implementing effective corrective and preventive actions, while monitoring CAPA effectiveness.
• Lead CAPA Investigations for complaint handling and vigilance reporting, ensuring timely initiation, execution, and closure of CAPAs in accordance with internal procedures and regulatory timelines.
• Apply structured problem-solving methodologies (e.g. 5 WHYs, Fishbone, Fault Tree Analysis) to conduct thorough root cause analyses.
• Analyze complaint trends and metrics to identify systemic issues and opportunities for improvement and initiate CAPAs.
• Drive continuous improvement initiatives aimed at refining the complaint handling process, and ensuring regulatory compliance through collaborative efforts, root cause analysis, and proactive implementation of corrective and preventive actions.
• Collaborate with cross-functional teams (Quality, Regulatory, R&D) to gather data and insights for complaint-related CAPAs to gather data, assess risk, and develop effective corrective and preventive actions.
• Maintain accurate and complete CAPA records in the electronic Quality Management System. Prepare CAPA summaries and metrics for operational reporting.
• Serve as a subject matter expert during audits and inspections by providing CAPA documentation and responding to inquiries.

Job Family Description:

Ensures timely and effective resolution of quality issues by leading root cause investigations, developing robust corrective and preventive actions, and driving continuous improvements.

Minimum Required Qualifications:

Education:

• Bachelor's/ Master's Degree in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management or equivalent.

Experience:

• Minimum 5 years of experience with Bachelor's in areas such as CAPA, Complaint Handling Operations, Medical Device, Quality Assurance, Quality Control, Clinical Research or equivalent OR no prior experience required with Master's Degree

Preferred Skills:

Technical / Functional Skills:

• CAPA Methodologies

• Root Cause Analysis (RCA)

• Continuous Improvement

• Data Analysis & Interpretation

• Post-Market Surveillance Mechanisms

• Quality Management Systems (QMS)

• Regulatory Requirements

• Complaint Management

• Vigilance Reporting