05/01/2026 13:34, Nhà đầu tư tuyển dụng
Amphenol CMT is looking for a Quality Assurance Lead to spearhead End-to-End product quality management and ensure strict QMS compliance (ISO 13485, FDA GMP). This role reports directly to the Technical Project Engineer.
Quality Leadership: Build and direct the product quality function, including customer, supplier, and process quality, as well as metrology and auditing.
QMS Compliance: Serve as the Management Representative for ISO 13485 and FDA GMP compliance, managing internal audits, document control, and process validation.
Continuous Improvement: Support efforts to improve quality data, first-pass yield, and scrap reduction while implementing operational best practices.
Issue Resolution: Lead cross-functional teams in root cause analysis and implement effective corrective and preventive actions (CAPA).
Non-Conforming Product: Lead the MRB team to manage and disposition non-conforming products.
Risk Management: Utilize a risk-based approach to mitigate high-potential failures within facility processes.
Metrology & Calibration: Maintain a calibration system for all production assets compliant with NIST traceable standards.
Education: Bachelor’s degree or above in Mechanical or Electrical Engineering.
Experience: 5+ years in the medical device industry (Product Quality, Quality System, or Program Quality).
Leadership: Proven experience supervising teams in a fast-paced environment.
Technical Expertise: Strong knowledge of ISO 13485, quality problem-solving methods, and statistical techniques (Six Sigma Black Belt is a plus).
Language: Clear verbal and written communication skills in both English and Vietnamese.
Skills: Proficient in Microsoft Office and experienced with statistical or document control systems.
Mindset: Detail-oriented, customer-centric, and able to handle multiple priorities under tight deadlines.
Salary: Competitive salary, to be discussed in detail during the interview 🤝💵.
Benefits: Comprehensive welfare package and professional growth opportunities will be shared during the interview ✨📈.
Contact Ms. Linh (0822 756 865) 📱 Please contact during business hours from 8:30 AM to 4:30 PM. 🕗