Sustaining Quality Engineer

Responsible for ensuring the quality and regulatory complianceof existing products in the medical industrySobre 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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