Quality Assurance Lead

• Build and direct the product quality function, including customer, supplier, and process quality, as well as metrology and auditing
• Serve as the Management Representative for ISO 13485 and FDA GMP compliance, managing internal audits, document control, and process validation
• Support efforts to improve quality data, first-pass yield, and scrap reduction while implementing operational best practices
• Lead cross-functional teams in root cause analysis and implement effective corrective and preventive actions (CAPA)
• Lead the MRB team to manage and disposition non-conforming products
• Utilize a risk-based approach to mitigate high-potential failures within facility processes
• Maintain a calibration system for all production assets compliant with NIST traceable standards

• Bachelor’s degree or above in Mechanical or Electrical Engineering
• 5+ years in the medical device industry (Product Quality, Quality System, or Program Quality)
• Proven experience supervising teams in a fast-paced environment
• Strong knowledge of ISO 13485, quality problem-solving methods, and statistical techniques (Six Sigma Black Belt is a plus)
• Clear verbal and written communication skills in both English and Vietnamese
• Proficient in Microsoft Office and experienced with statistical or document control systems
• Detail-oriented, customer-centric, and able to handle multiple priorities under tight deadlines

Six Sigma Black Belt

• Comprehensive welfare package
• Professional growth opportunities