Direct message the job poster from BVI Medical BVI® is a global ophthalmic medical device manufacturer with a mission to deliver high quality solutions and innovation for advancing eye surgery and improving the vision of patients. 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 team supports surgical teams, in more than 115 countries worldwide, either directly or through our network of trusted distributors. Our trusted brands include Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium Intraocular Lenses). Education & Business Experience Requirements Minimum 3 to 5 years’ experience as a Quality Engineer in the medical device industry BA/BS degree in science or other technical field. Experience in starting and transferring operations abroad to Mexico. Medical Device Quality System Knowledge Including 21 CFR Part 820 (QSR) & ISO 13485 Demonstrated skills in statistical analysis. Individual must have a hands-on approach. Experience participating in internal and external audits (e.g., FDA, Suppliers) Strong organizational and time management skills. Experience with CAPA, complaint investigation, field action processes and risk management. CQE, CQA preferred Required Competencies Recognized as a technical leader within the company and engenders trust when working with customers or suppliers Capable of leading a Continuous Improvement Team, CAPA team, or working with a customer or supplier to resolve product quality issues Works effectively on cross functional teams to establish appropriate processes pertaining to quality Communication Excellent written and oral communication skills Ability to formulate responses to common inquiries or complaints from customers and regulatory agencies Ability to review, analyze, summarize, and interpret data; draw conclusions and make appropriate recommendations and decisions; write reports; and give oral presentations Description of Responsibilities The Quality Engineer is responsible for reviewing and analyzing complaint data, performing root-cause investigations to establish corrective action plans and implement corrective actions, developing and performing test methods for product testing and investigations, writing and updating procedures as required to ensure the quality system is compliant with regulations including the FDA Quality System Requirements (QSR), ISO 13485, Canadian Medical Device Regulations (EU MDR), and the Medical Devices Directive (MDD). Seniority level Mid-Senior level Employment type Full-time Job function Manufacturing and Medical Equipment Manufacturing Referrals increase your chances of interviewing at BVI Medical by 2x Get notified about new Quality Assurance Engineer jobs in Juárez, Chihuahua, Mexico . We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr