Senior Design Quality Engineer
Outset Medical Mexico
Required Qualifications Bachelor’s degree in Engineering or Science (or similar) is required. Master’s degree is preferred. Minimum of 7 years of hands-on experience in the Quality Engineering discipline. Prior experiences in the medical device field is required; preferably experience with Capital Equipment and single use medical devices. Knowledge of FDA Quality System requirements, ISO 13485 (Quality System) requirements, ISO 14971 (Risk Management) requirements, Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards. Must be able to communicate fluently in both written and spoken English Desired Qualifications Ability to work effectively in a fast paced and dynamic environment. A self-starter, motivated and able to positively motivate others. Focused, target driven with a positive, can-do attitude. Drive to assigned objectives which delivers best practice results, added value and continuous improvements across the business and quality management system. Leadership and interpersonal skills to develop and manage good working relationships with internal departments (manufacturing, receiving, purchasing, product development, and regulatory), contractors, and suppliers. Strong written and verbal communication skills. Certified Quality Engineer a plus. Lead Auditor certification a plus. Lean Certification a plus. Experience with statistical analysis software a plus
Hace 2 horas en Tijuana
