Soon Chun Vue Email & Phone Number

Minneapolis, Mn, Us

Eden Prairie, Mn, Us

Eden Prairie, Mn, Us

• Head or support oversight to all of Harland Medical Quality Procedures, review yearly and improve to support overall compliance to ISO 13485 standards and FDA regulations• Creates and maintains Quality documentation to support Customer requirements and regulation• Create, review, and approve Document Change Orders (i.e., change control management) to ensure documentation are up to industry and company standards• Create, review, and approve COAs and COCs as required• Create/maintain/track and report all Quality System Site Management Review Metrics as required• Investigate and resolve product and process complaint nonconformities• Manage CAPA programs as required• Lead investigation of product, services, or internal business processes to identify and correct• issues causing non-compliance of product to specification• Perform, direct, and support internal and external audits of the quality system• Help with Regulation implementation and filing requirements• Evaluate, review and approve testing/reports for combination drug products to ensure products are up to industry and company standards as required• Perform lab investigations as required• Create new and improved quality systems• Provide main Customer communications• Risk management planning and reporting• Support regulatory filings such as MFAs• Stability and shelf-life testing• Perform other quality control testing duties as required• Manage the quality department design controls for new products• Support external audits initiated by customers and regulatory agencies, and internal audits• Ability to create a budget for department

Eden Prairie, Mn, Us

• Ensures compliance to external and internal Quality Standards for Manufacturing and Product Development • Creates and manages policies and procedures for identifying, analyzing risk throughout the product life cycle• Perform product and process risk control measures (i.e., pFMEA, dFMEA risk evaluation) and risk management files (i.e., control plans, reports, safety profiles)• Create and develop evaluations, tests, and makes decisions to maintain Quality Objectives • Manages and ensures implementation of Quality Processes, Procedures and Techniques • Manages Internal Non-Conformities, Manufacturing Deviations and Corrective and Preventative Actions • Lead audits and investigations of products, services, or internal business processes to identify and correct issues causing non-compliance of product to specification, escape of non-conformances to customers or ineffectiveness of a business system to achieve its intended purpose

Eden Prairie, Mn, Us

• Ensures compliance to external and internal Quality Standards for Manufacturing and Product Development • Follows policies and procedures for identifying, analyzing risk throughout the product life cycle • Support product and process risk control measures (i.e., pFMEA, dFMEA risk evaluation) and risk management files (i.e., control plans, reports, safety profiles)• Assists in evaluations, tests, and decisions to maintain Quality Objectives • Follows Quality Processes, Procedures and Techniques • Assists on actions related to Internal Non-Conformities, Manufacturing Deviations and Corrective and Preventative Actions • Assists in audits and investigations of products, services, or internal business processes to identify and correct issues causing non-compliance of product to specification, escape of non-conformances to customers or ineffectiveness of a business system to achieve its intended purpose • Assists in equipment calibration and maintenance program as necessary• Perform Device History Record (DHR) review to ensure manufacturing documentation are accurate and complete as necessary

Brea, California, Us

• Investigated Immunoassay Safety Complaints and assessed reportability with no late file submissions to the FDA• All non-escalation Safety complaints submitted within 30 day timeline• 2 years of leading PMI (Post Market Investigations) Daily Management and cross-functional teams• Developed standard work for PMI (Post Market Investigations) investigation activities to contribute to positive OTD (On time delivery) metrics• Perform Risk Assessments, determine CAPA eligibility, Stop Ship, and Field Action assessment• Developed Visual Stream Map for project inputs and identified gaps and best practices• Utilized Microsoft Power Automate and SharePoint to develop input forms for 3 different product lines.

Brea, California, Us

• Investigated Immunoassay Quality Complaints and ensured no misclassified complaints processed• Achieved proficiency in Excel and Macro to develop workbook to efficiently distribute workload. • Reduced space in returned hardware parts zone by more than 50%• Developed process to reduce Quality complaint investigations by 15 minutes per complaint. • Daily and Weekly Maintenance performed on 2 Immunoassay devices

• Obtained blood samples for testing through venipuncture or capillary puncture• Ran and operated Siemens Xpand Plus analyzer for chemistry patient samples• Ran and operated COULTER® Ac·T™ 5 and COULTER® Ac·T™ 2 analyzer for hematology patient samples• Performed routine Quality controls and Calibrations• Maintained best laboratory and documentation practices

Bachelor Of Science (Bs), Biology, General

Associate Of Applied Science (A.A.S.), Medical Laboratory Technician

High School