BVI® is a diversified global ophthalmic device company with a mission to deliver high-quality solutions and innovation for advancing eye surgery and improving patients’ vision. With nine decades of developing leading products and solutions, BVI partners with ophthalmic surgeons to improve the vision of millions of patients across the globe. Our organization supports surgical teams in more than 90 countries worldwide, either directly or through our network of trusted distributors. Requirements: 5 + years of experience in Quality, Engineering, regulatory, or Operations discipline BS/BA degree or above engineering, quality, biomedical or another related fields related to manufacturing industry Bilingual: English / Spanish Experience in Root Cause Analysis and Corrective and Preventive Action solutions Experience, knowledge, ISO 13485, MDSAP, MDR and other related international standards Experience utilizing Lean/Six Sigma or other contemporary methodologies and tools for continuous improvement Strong Statistical Process Control knowledge, including interpretation and implementation Familiarity with and Expertise in Preventative tools - SPC, PFMEA, QFD, risk base management to reduce risk to product quality Maintain flexibility to react quickly to changes in priorities or circumstances to meet the needs of the business Maintain awareness of the state of the industry and evaluate emerging trends/developments that may benefit the organization Experience building and maintaining relationships with multiple customers or partners (both internal and external to the company) General knowledge of industry technical standards (such as ISO, ANSI, CMMI, ASTM, etc.) Six Sigma , Lean and / or American Society for Quality (ASQ) Certification (CQE, CQM/OE, CSQE, CQA, CRE, etc) Excellent in written / verbal communication and presentation skills (80+) Determine project quality requirements and perform quality planning activities Experience participating in internal and external audits (e.g., FDA, Suppliers)