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Christine Wu

Christine Wu

Senior Customer Quality Specialist

Advanced Sterilization Products (ASP)

Orange County, California Area

Seeking to expand my knowledge and experience in the medical device industry where my results-driven work ethic, attention to detail, collaboration skills across various functional groups, and strong analytical capacity are required.

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Advanced Sterilization Products (ASP)

Senior Customer Quality Specialist

• Trained and coordinated 10 on-site junior analysts to analyze, investigate, and resolve complaints resulting in the resolution of 24,000 international complaints within one year
• Reviewed, approved and closed high visibility product and reportable complaints. Ensured quality issues were investigated, resolved and closed in an effective and timely manner
• Review and respond to monthly internal audit concerns and findings
• Participate in weekly Adverse Event meetings to discuss potential reportable events and help facilitate communication to retrieve time sensitive information from customers so reportability decisions can be made correctly and in a timely manner
• Make reportability decisions and file Regulatory Reports
• Involved in developing and deploying a new complaint submission process to enhance collaboration between WW affiliates resulting in improved relations and communication
• Trained and led an offshore team of 15 analysts by managing their complaints entry workflow
• Responsible for monitoring worldwide complaints reporting for the company and driving complaints
reporting timeliness
• Streamlined Return Materials Authorization process that resulted in the cycle time reduction from an average of 2 months to 1 day to avoid compliance issues.
• Supported backroom operations of an audit

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