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

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

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

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

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