Randy Duong Email & Phone Number

Mountain View, California, US

Kalamazoo, MI, US

• Post Market Surveillance
• Review customer product complaints via Trackwise and determine if reportability to FDA and international regulatory authorities is required.
• Monitor quality, completeness, and timeliness of product complaint investigations, risk assessment, and product complaint conclusion from product assessment center team.
• Partner with sales representatives using Salesforce CRM and health care professionals to obtain additional complaint information.Master Data Management
• Upload batch/product information into ERP system (SAP, Oracle R12, Oracle R11i) for products to be received at the distribution centers or shipped to customers.
• Assisting quality team members with product rework requests for redistribution.

Durham, North Carolina, US

• Process Improvement
• Conducted gap assessment to streamline implementation of training requirements for new hires with 5S methodology and RACI matrix.
• Enhanced training compliance and quality data metrics for monitoring and measurement with pivot tables, charts, and xlookup functionality maintaining a 95% compliance rate for 30,000 new and obsolete training records.
• Partnered with Senior Document Controller to advance training program with addition of competency assessments in compliance with Medical Device Single Audit Program regulation (MDSAP, 2020).
• Served as Training Program Manager during Internal and External Audits for QMS Training.
• Presented in quarterly QMS Management Review meetings showcasing training metrics and charts per department, location, and new hires.Computer System Validation

Durham, North Carolina, US

• Human Resources Management
• Conducted new hire training, introduced company policies and benefits provided through ADP, and processed termination interviews.
• Worked with Senior HR Manager, VP of HR, and hiring managers to execute recruiting process via Taleo. Source resume per job description, schedule candidates for interviews, and process new hire paperwork.
• Facilitate open enrollment by educating employees on benefits and processing employee changes.
• Follows up to obtain required documents from employees (I9 eligibility, background investigation report, FMLA, benefits enrollment).
• Worked with Senior HR Manager and VP of HR to document ISO certified job descriptions per Human Resources Monthly Company Headcount in compliance with ISO 13485.Document Control and Training Management