About acon labs:acon laboratories' tijuana facility is a key manufacturing site within a global organization dedicated to delivering high-quality diagnostic and medical products. The site operates under strict regulatory standards and plays a critical role in supporting international markets through innovation, quality, and compliance.job description:we are looking for a bilingual (english/spanish) production quality engineer with 5+ years of experience in the medical device industry under iso * and fda 21 cfr 820/qmsr.key focus:lead and manage tj site core quality systems: ncmr, capa, change control (cor), manufacturing deviations.maintain the master validation plan (mvp) and support validation activities.administer and maintain the approved supplier list (asl).manage scars, supplier kpis, and ensure timely closure of quality issues.review and approve device history records (dhrs).perform final product release and generate certificates of analysis.investigate nonconformances ncmr ´s, capas, and customer complaints related with assigned process.participate in process validations and pfmea developmentperform data analysis and kpi trending to support decision-makingproject management to support quality improvement projects.collaborate cross-functionally with manufacturing, r&d, and supply chain.qualifications:bachelor's degree in engineering, life sciences, or related field.fully bilingual: english & spanish (written and verbal).5+ years of experience in quality engineering within the medical device industry.strong knowledge, iso *, fda 21 cfr part 820 (qmsr), iso * (risk management).experience with audits, validations, and regulatory inspections.strong analytical, organizational, and communication skills.proficiency in ms office (excel, word, powerpoint, project).