Product Release Specialist

Intuitive Surgical; Mexicali; Presencial; MXN 400,000 - 600,000; Jornada completa

Descripción de la vacante

A medical device company in Mexicali is hiring a Product Release Specialist responsible for ensuring compliance with quality requirements. The role involves reviewing manufacturing records, managing non-conforming products, and collaborating with cross-functional teams. Candidates should have 4-6 years of relevant experience and strong bilingual communication skills in English and Spanish. This position supports the development of innovative surgical solutions and offers the opportunity to contribute positively to patient care.

Formación

• 4-6 years of related experience in Product Quality role within a medical device company.
• 6 months of relevant experience as Product Release Associate.
• Ability to work in a team environment.

Responsabilidades

• Review and approve manufacturing Device History Records for compliance.
• Coordinate transfers of non-conforming material between plants.
• Escalate quality issues impacting safety and efficacy.

Conocimientos

Product Quality experience

Communication skills in English and Spanish

Integrity

Problem-solving skills

Strong computer skills

Educación

High School, Technical Diploma or Bachelor's degree

Herramientas

Microsoft Office

ERP systems (preferably SAP)

Descripción del empleo

Company Description

It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally invasive care, our technologies—like the da Vinci surgical system and Ion—have transformed how care is delivered for millions of patients worldwide.

We’re a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.

The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful—because every improvement we make has the potential to change a life.

If you’re ready to contribute to something bigger than yourself and help transform the future of healthcare, you’ll find your purpose here.

Job Description

Primary Function of Position

The Product Release Specialist will work with multidisciplinary teams dedicated within Manufacturing, FQI, Planning and Engineering to assure compliance to of finished product quality system requirements, with the purpose to identify discrepancies related to traceability, requirements on the Device History Record, Rework of non-conforming products, ECO and Deviation implementation, Shipments of products to the sterilizer and help with the resolution of such discrepancies in order to authorize release of product to customers.

Essential Job Duties

• Reviews and approves manufacturing Device History Records for all assembly levels, ensuring compliance with device master records and other Quality System requirements.
• Performs the following process as necessary:
  • Review and release of ISI products, including Instruments, Accessories and Endoscopes (Refurbish) for distribution according to the stablished procedures.
  • Review and approve any non-conformances documented on the Device History Record
    • Documents non-conformances through the corresponding quality notification (NCR, VR, DN) on ISI electronic documentation system.
    • Handling, storage and monitor of non-conforming inventory in the quarantine areas, performing cycle counts and delivering products to manufacturing operations for sorting or rework.
    • Processing of dispositioned material - scrapping of parts from NCRs
    • Coordinates transfers of non-conforming material between plants.
  • Review and approve of shipments of Single Use Devices to the sterilization process with the sterilization contractors.
  • Review, approve and release of sterile products manufactured by Intuitive or from a Contract Manufacturer.
• Works collaboratively with cross functional teams and external customers to resolve non-conformances on a timely manner.
• Performs inventory transactions and ensures that released products are transacted in a timely manner to maintain inventory accuracy for department inventory locations.
• Escalates areas of concern to the Quality Assurance department and direct management.
• Performs all work according to Quality standards as set by the Quality Assurance department and direct management.
• Performs all work according to production, planning and logistics schedule, including working overtime as required.
• Escalating to the Quality Assurance department and direct management all Quality issues that could impact patient safety, surgical efficacy or traceability.
• Compliance with company department and standard operation procedures.
• Leads and participates in department process improvement projects or other activities as directed by management.
• Maintains a strong understanding of QMS procedures for directly adjacent departments (i.e., Manufacturing, Planning, FQI, Logistics, Engineering).
• Supports internal and external audits as required.
• Solve concerns of his colleagues and members of other departments about their procedures.
• Provides support to Manufacturing Engineers during PPQ’s.
• Acts as a mentor for personnel in training in case of absence of the Product Release leader.
• Ensuring successful, on-time completion of department projects; communication constraints to direct management when successful project completion is a risk.
• Publishes Quality and operational metrics to direct management as required.

Qualifications

Required Skills and Experience

• Typically requires a minimum of 4 - 6 years of related experience in Product Quality role within a medical device company (Preferred).
• Typically requires a minimum 6 months of relevant experience as Product Release Associate.
• Good verbal and written communication skills in English and Spanish
  • Ability to read and comprehend instructions, write short correspondences and memos, complete quality documentation in English and Spanish.
  • Effectively present information in one on one and small group situations involving employees, supervisors or engineers.
• Integrity: Accepting and adhering to high ethical, moral, and personal values in decisions, communications, actions and when dealing with others.
• Demonstrated ability to work independently and with minimal supervision, multi-task, and handle tasks with competing priorities effectively.
• Ability to work in a team environment and with cross-functional teams.
• Very strong computer skills and experience with Windows operating system and Microsoft Office.
• Availability to work on different Shifts as needed.

Required Education and Training

• High School, Technical Diploma or Bachelor’s degree.

Working Conditions

• Ability to move heavy material (Pallets) with a Pallet Jack on a frequent basis (if required).
• Walking and repetitive physical motion like squatting, bending and lifting (if required).
• Ability to work in a controlled environment room (i.e., clean room)
• Personal Protection Equipment: Safety Shoes and Safety Glasses

Preferred Skills and Experience

• Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements including, but not limited to, ISO13485 and U.S. FDA 21CFR820.
• Demonstrated ability to be a quick learner and understand complex products and processes.
• Excellent analytical, problem-solving, and root-cause analysis skills.
• Ability to travel domestically and internationally.
• Demonstrated interest in Medical devices, anatomy, surgery and the medical field.
• Excellent computer experience on ERP systems (preferably SAP/Agile or other Electronic Documentation Systems).
• High motivation and enthusiasm as well as a pronounced awareness of quality, order, and cleanliness.

Additional Information

Intuitive es un empleador que brinda igualdad de oportunidades de empleo. Proporcionamos igualdad de oportunidades de empleo a todos los solicitantes y empleados cualificados, y prohibimos cualquier tipo de discriminación y acoso, independientemente de su raza, sexo, condición de embarazo, orientación sexual, identidad de género, origen nacional, color, edad, religión, condición de veterano protegido o de discapacidad, información genética o cualquier otra condición protegida por las leyes federales, estatales o locales aplicables.

Aviso sobre los Controles de Exportación de EE. UU.: De acuerdo con las Regulaciones de Administración de Exportaciones de EE. UU. (15 CFR §743.13(b)), algunos puestos en Intuitive Surgical pueden estar sujetos a controles de exportación de EE. UU. para candidatos que sean nacionales de países actualmente bajo embargo o sanciones.

Cierta información que usted proporcione como parte de la solicitud será utilizada para determinar si Intuitive Surgical necesitará (i) obtener una licencia de exportación del gobierno de EE. UU. en su nombre (nota: el proceso de obtención de la licencia puede tardar entre 3 y más de 6 meses) o (ii) implementar un Plan de Control de Tecnología (“TCP”, por sus siglas en inglés) (nota: normalmente este paso agrega 2 semanas al proceso de contratación).
Para cualquier puesto en Intuitive sujeto a controles de exportación, las ofertas finales están condicionadas a la obtención de una licencia de exportación aprobada y/o a la ejecución de un TCP antes de la fecha de inicio del empleado potencial, la cual puede o no ser flexible, y dentro de un plazo que no obstaculice de manera irrazonable la necesidad de contratación. Si aplica, los candidatos serán notificados e instruidos sobre cualquier requisito relacionado con estos fines.

Shift: Day