Risk Management Quality Engineer

Job Title

Job Description

Job Responsibilities:

• Executes low complexity post market surveillance processes, adheres to predefined parameters and guidelines, optimizes efficiency and effectiveness, and fosters consistency and reliability in operations to maintain a high level of quality and performance within the established framework of operational procedures.
• Conducts operations and reporting procedures to ensure efficient tracking and monitoring of execution progress, enabling effective decision-making and resource allocation aligned with strategic goals.
• Develops and delivers comprehensive reporting tools to facilitate informed decision-making and performance evaluation across the organization, enabling proactive management and strategic planning initiatives.
• Collaborates closely with business process experts to execute comprehensive training initiatives, delivers effective training programs tailored to meet the specific needs of the organization, and fosters skill enhancement and knowledge transfer across various business processes.
• Conducts quality assurance assessments on developed communication tools, ensures that the tools meet stringent standards for precision and efficacy and evaluates their accuracy in reporting and effectiveness in generating response plans.
• Gathers and merges data from diverse sources, consolidating it into a cohesive and actionable perspective to provide a comprehensive view that enables informed decision-making and facilitates effective implementation of strategies and initiatives across the organization.
• Documents and maintains meticulous records of post-market surveillance activities to ensure accuracy, compliance, and accessibility for monitoring product safety and facilitating timely responses to emerging market trends.
• Compiles and analyze continuous product performance data to identify any safety issues, performance deviations, or trends that may require further investigation.
• Supports the preparation of post-market surveillance documentation, ensures adherence to regulations and guidelines, and collaborates with clinical affairs and stakeholders to compile necessary documentation, such as post market surveillance plans and reports.

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

Minimum required Experience:
No prior experience required with Bachelor's OR minimum 4 years of experience in Post Market Surveillance Operations, Medical Device, Quality Assurance, Quality Control, Clinical Research or equivalent.

Preferred Language:

Chinese (native or fluent)

English (fluent)

Preferred Skills:
• Post-Market Surveillance Mechanisms
• Quality Management Systems (QMS)
• Regulatory Requirements
• Technical Documentation
• Project Management
• Training Delivery
• Quality Assurance (QA)
• Business Intelligence Tools
• Data Management

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.
About Philips
Are you ready to do the work of your life to help the lives of others? Learn more about our business, discover our rich and exciting history and learn more about our purpose.
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.