Sr Quality Engineer
Biotix International, S. de R.L. de C.V.
QUALITIFICATIONS: · Bachelor’s degree in industrial, Mechanical, Electronic, Biomedical Engineering or related field. EXPERIENCE SUMMARY: · 5+ years of experience in quality roles within manufacturing or regulated industries. · Proven experience leading improvement projects and resolving complex quality issues. SKILLS AND COMPETENCIES: · Technical Skills (Hard Skills): Strong knowledge of quality standards and regulations (ISO 9001, ISO 13485, 21 CFR Part 820). Proficient with quality tools: FMEA, SPC, MSA, 8D, 5 Whys, Ishikawa. Ability to read and interpret technical drawings and product specifications. Experience with ERP, MES, and statistical tools (Minitab, advanced Excel). Solid understanding of validations (IQ/OQ/PQ), auditing, and technical documentation. · Soft Skills: Technical leadership and mentoring capabilities. Strong problem-solving and decision-making skills. Effective communication with cross-functional teams. Results-driven with a focus on continuous improvement. Project management and prioritization.
Mayo 19 2025 en Tijuana