* responsible for ensuring the quality and regulatory compliance
* of existing products in the medical industry
sobre nuestro cliente
international contract manufacturing company for medical products.
descripción
* support and ensure the quality of products already in the market.
* investigate and resolve quality issues for released products.
* manage non-conformance reports (ncr) and lead corrective and preventive actions (capa).
* lead process validations, including iq, oq, and pq, for sustaining products.
* ensure compliance with regulatory standards (fda, iso 13485, etc.).
* manage product documentation updates (dhf, dmr, etc.) and handle change control processes (ecos).
* collaborate with suppliers and customers to resolve quality-related issues.
* monitor product quality data and lead continuous improvement initiatives.
perfil buscado
must
* bachelor's degree in engineering, quality, or related field.
* 3+ years of experience in quality engineering and sustaining.
* proven experience in the medical device industry.
* experience working in high-volume, high-paced manufacturing environments.
* strong knowledge of regulatory requirements (fda, iso 13485, pmda, mdr, etc.) and quality management systems (qms).
* experience with root cause analysis, capa, ncr, and process validations.
* proficiency in statistical analysis tools (spc, minitab, etc.).
* excellent problem-solving and communication skills.
* hands-on, proactive approach.
* advanced english proficiency.
* location: tijuana.
qué ofrecemos
competitive salary + benefits.
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