CH Operations Expert

Job Title

Job Description

Job title:
CH Operations Expert:

Responsible for overseeing complaint handling processes, facilitating communication between stakeholders, resolving complex complaints by liaising with business/market/clinical/product experts, mentoring and training new specialists, leading investigation teams, and ensuring accurate vigilance reporting to enhance product quality and customer satisfaction. The role provides guidance on mid-complexity product-specific concerns, responding to moderate questions from complaint evaluators and investigators to ensure effective communication and support. The role analyzes the quality of the complaint handling process, scrutinizing performance and identifying areas for business process improvements. The role ensures timely global medical device reporting by assessing complaints against reporting requirements and facilitating any required further investigation.

Your role:

• Provides information on mid-complexity product-specific concerns, responds to moderate questions from complaint evaluators and complaint investigators, ensuring effective communication and support throughout the process.
• Analyzes the quality of the complaint handling process, scrutinizes the performance of both the complaint evaluator and investigator, identifies bottlenecks and challenges encountered during the process and pinpoints areas for business process improvements to streamline operations and enhance customer satisfaction.
• Works under limited supervision and broad guidelines and resolves complex complaints, evaluates initial assessments of reportability, promptly escalates to the manager for further determination and necessary action and ensures thorough analysis and resolution.
• Facilitates the training and qualification process for new PMS complaint operations specialists, provides hands-on assistance, creates, and documents training materials, and offers ongoing mentorship and feedback to cultivate their skills and confidence.
• Leads a team of specialists, analyzes complaint data comprehensively, collaborates cross-functionally for constructive feedback, governs screening, evaluation, and monitoring of complaints across product and non-product realms, and ensures accuracy in service record coding as a crucial input to the complaints process.
• Compiles and monitors team performance offers supplementary support to the PMS complaint operations management and assists in various requested activities to ensure smooth operations and effective resolution of issues.
• Generates periodic reports on complaint trends and metrics, ensures accurate and timely documentation for internal review and regulatory submission, and maintains compliance with relevant standards.
• Participates in continuous improvement initiatives aimed at refining the complaint handling process, ensuring regulatory compliance, and enhancing overall product quality through collaborative efforts, root cause analysis, and proactive implementation of corrective and preventive actions.
• Utilizes an advanced knowledge of regulations, requirements, and standards to execute tasks within post-market surveillance complaint operations, ensuring adherence to regulatory mandates and facilitating effective management and resolution of complaints.
• Cultivates effective relationships with internal/external partners and provides influence over projects and peer groups, demonstrating full understanding of area of specialization.

Minimum required Education:
Bachelor's/ Master's Degree in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management or equivalent.

Minimum required Experience:
Minimum 14+ years of experience with Bachelor's in areas such as Complaint Handling Operations, Medical Device, Quality Assurance, Quality Control, Audit Support.

Preferred Skills:
. Post-Market Surveillance Mechanisms
. Quality Management Systems (QMS)
. Quality Specifications
. Data Analysis & Interpretation
. Regulatory Requirements
. Root Cause Analysis (RCA)
. CAPA Methodologies
. Continuous Improvement
. Quality Risk Management
. Complaint Management
. Vigilance Reporting
. Training Delivery
. Training Content Development
. FDA Audit Experience

How we work together
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week.
Onsite roles require full-time presence in the company's facilities.
Field roles are most effectively done outside of the company's main facilities, generally at the customers or suppliers locations.
Indicate if this role is an office/field/onsite role.
About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
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If you're interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care .