CH Operations Expert

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:
u2022 Post-Market Surveillance Mechanisms
u2022 Quality Management Systems (QMS)
u2022 Quality Specifications
u2022 Data Analysis & Interpretation
u2022 Regulatory Requirements
u2022 Root Cause Analysis (RCA)
u2022 CAPA Methodologies
u2022 Continuous Improvement
u2022 Quality Risk Management
u2022 Complaint Management
u2022 Vigilance Reporting
u2022 Training Delivery
u2022 Training Content Development
u2022 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 companyu2019s facilities.
Field roles are most effectively done outside of the companyu2019s main facilities, generally at the customersu2019 or suppliersu2019 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 youu2019re 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 .