Quality Engineer II

Duties and Responsibilities Reviews and investigates product problems and/or customer complaints or other nonconformities, including evaluating the quality system; determination of root cause and recommend corrective and preventive actions where required (complaints, CAPAs and NCRs). Provide quality support in products as well as in project development. Act as quality representative for quality issues in transfer products. Lead projects related to the improvement of products and processes. Provide feedback to manufacturing engineering to reduce rejects and reduce non-conforming material. Use quality tools to solve problems related to your business unit. Formulate and present statistical data reports and monitoring of your business unit. Provide support and support in validations of manufacturing processes in your business unit. Carry out inspections and/or tests of products, raw materials, equipment or accessories according to established specifications using special test equipment including where necessary development of test equipment specifications and protocols. Participates in mandatory business unit meetings and weekly meetings and prepares and presents information and documentation associated with Quality engineering activities. Provide support to internal audits as well as the preventive identification of opportunities for improvement in processes and quality system. Support in the administration of new revised methods when required. Execute and comply with the specific activities and requirements described by the documented quality system. Know and apply the policies and procedures of the Quality Systems, ISO 13485, Occupational Safety, and any other system that the company requires for its operation. This position may have personnel under its responsibility (Quality inspectors). Experience and requirements Engineering degree from a 4 year University Program. 3-5 years of experience in quality engineering in the medical device manufacturing industry. Experience in FDA regulations of medical products Excellent ability to communicate orally and in writing in English/Spanish. Knowledge of quality systems required in relation to ISO13485

Location: Baja California, MX

Posted Date: 4/26/2025