Sr Quality Engineer
hace 1 semana
Descripción y detalle de las actividadesThe Sr. Quality Engineer will be responsible for development procedures and deliverables, ensuring their compliance with ICU Medical quality system requirements and applicable regulations and standards (such as ISO 13485, ISO 14971, 21 CFR Part 820, and other applicable regulations and standards). The Sr. Quality Engineer will provide quality assurance support for product realization/manufacturing teams. Reporting to the Quality Manager, this individual will be the Quality Core Team Member for ensuring products are developed/manufactured utilizing appropriate processes to design the highest level of quality into products as they are developed.Essential Duties & ResponsibilitiesEffectively utilize quality tools and processes such as product and process controls, risk analysis/management tools, validation, design verification, investigations, CAPA data, etc. to assure product quality.Assures conformance with regulations of the FDA and other international regulatory agencies and may assist in providing responses to the FDA and other regulatory agencies with respect to medical device compliance.Provides compliance guidance concerning development, application, and maintenance of quality standards as related to product development within the quality system.Work with cross-functional teams to coordinate product changes.Participate in design reviews, test readiness reviews, cross functional teams, risk assessments, design transfers, etc.Provide corporate quality support, guidance and direction for bringing on-market product issues to closure and escalating to senior management for support as necessary.Ensure that potential product and process risks are evaluated, prioritized, and mitigated to continuously improve product quality.Utilize a wide variety of data sources including product review, global complaints, manufacturing quality data, etc. Monitor product data to identify statistically significant trends and risks.Experiencia y requisitosBachelor’s degree in engineering from an accredited college or university is required.Minimum of 7+ years similar role in Medical Device IndustryASQ CQE or CSQE required or the ability to obtain within one year.Strong knowledge of medical device standards, including but not limited to: ISO 13485, ISO 14971, FDA, MDR and other key medical device regulations.Experience linking risk management to all elements of the QMS (Design Controls, CAPA, Complaints, Doc Control, etc)Excellent Bilingual Spanish/English verbal and written communication skillsBeneficiosGuarderíaUtilidades garantizadasseguro de vidacaja de ahorrocomedorfondo de ahorrotransporteseguro de gastos médicosplan de indexaciónservicios médicos en planta #J-18808-Ljbffr
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Sr Quality Engineer
hace 3 semanas
Tijuana, México Prodensa A tiempo completo**Posición**: Sr Quality Engineer**Zona**: Tijuana, BC**Requisitos**:Ingeniería industrial o afín5 años de experiência en pueso afinExperiência en manufactura de dispositivos médicosInglés indispensableAtención a auditoríasEnfoque en procesos de producciónResolución de problemas en línea**Ofrecemos**: Sueldo competitivo más prestaciones...
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Sr Quality Engineer
hace 1 semana
Tijuana, México ICU Medical A tiempo completoThe Sr. Quality Engineer will be responsible for development procedures and deliverables, ensuring their compliance with ICU Medical quality system requirements and applicable regulations and standards (such as ISO 13485, ISO 14971, 21 CFR Part 820, and other applicable regulations and standards). The Sr. Quality Engineer will provide quality assurance...
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Sr Quality Engineer
hace 1 semana
Tijuana, México ICU Medical A tiempo completoThe Sr. Quality Engineer will be responsible for development procedures and deliverables, ensuring their compliance with ICU Medical quality system requirements and applicable regulations and standards (such as ISO 13485, ISO 14971, 21 CFR Part 820, and other applicable regulations and standards). The Sr. Quality Engineer will provide quality assurance...
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Sr. Supplier Quality Engineer
hace 4 semanas
Tijuana, México Bose A tiempo completoYou know the moment. It’s the first notes of that song you love, the intro to your favorite movie, or simply the sound of someone you love saying “hello.” It’s in these moments that sound matters most.At Bose, we believe sound is the most powerful force on earth. We’ve dedicated ourselves to improving it for nearly 60 years. And we’re passionate...
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Sr. Supplier Quality Engineer
hace 4 semanas
Tijuana, México Bose A tiempo completoYou know the moment. It’s the first notes of that song you love, the intro to your favorite movie, or simply the sound of someone you love saying “hello.” It’s in these moments that sound matters most.At Bose, we believe sound is the most powerful force on earth. We’ve dedicated ourselves to improving it for nearly 60 years. And we’re passionate...
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Sr. Supplier Quality Engineer
hace 1 día
Tijuana, México Bose A tiempo completoYou know the moment. It’s the first notes of that song you love, the intro to your favorite movie, or simply the sound of someone you love saying “hello.” It’s in these moments that sound matters most. At Bose, we believe sound is the most powerful force on earth. We’ve dedicated ourselves to improving it for nearly 60 years. And we’re...
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Sr. Supplier Quality Engineer
hace 1 día
Tijuana, México Bose A tiempo completoYou know the moment. It’s the first notes of that song you love, the intro to your favorite movie, or simply the sound of someone you love saying “hello.” It’s in these moments that sound matters most. At Bose, we believe sound is the most powerful force on earth. We’ve dedicated ourselves to improving it for nearly 60 years. And we’re...
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Sr. Supplier Quality Engineer
hace 1 semana
Tijuana, México Bose A tiempo completoYou know the moment. It’s the first notes of that song you love, the intro to your favorite movie, or simply the sound of someone you love saying “hello.” It’s in these moments that sound matters most. At Bose, we believe sound is the most powerful force on earth. We’ve dedicated ourselves to improving it for nearly 60 years. And we’re...
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Sr. Supplier Quality Engineer
hace 1 semana
Tijuana, México Bose A tiempo completoYou know the moment. It’s the first notes of that song you love, the intro to your favorite movie, or simply the sound of someone you love saying “hello.” It’s in these moments that sound matters most.At Bose, we believe sound is the most powerful force on earth. We’ve dedicated ourselves to improving it for nearly 60 years. And we’re passionate...
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Senior Quality Engineer: Medical Device Design
hace 1 semana
Tijuana, México ICU Medical A tiempo completoA leading medical device company in Tijuana, Mexico seeks an experienced Sr. Quality Engineer. The role involves ensuring product compliance with quality standards and regulations, utilizing quality tools, and coordinating with cross-functional teams. The ideal candidate has a Bachelor's degree in engineering, 7+ years of experience in the medical device...
