Product Release Associate

Intuitive; Mexicali; Presencial; MXN 180.000 - 240.000; Jornada completa

Descripción de la vacante

Intuitive in Mexicali, Baja California, is seeking a Product Release Associate to ensure compliance with finished product quality systems. The role involves reviewing Device History Records, releasing ISI products, handling non-conformances, and coordinating with Manufacturing, Planning, and Quality teams to authorize product release.

Requirements include 2 years in medical device QA, strong English and Spanish communication, and proficiency with quality documentation systems and ERP tools.

Formación

• Minimum 2 years of relevant experience in a Product Quality role within a medical device company.
• Strong written and spoken English and Spanish skills.
• Ability to read and understand instructions, produce quality documentation in both languages.
• Independent working capability with multitasking and prioritization.
• Ability to work in a team and cross-functional environment.
• Proficient computer skills and MS Office knowledge.

Responsabilidades

• Review and release of Device History Records for assembly levels.
• Inspect and release ISI products and refurbishments per procedures.
• Document non-conformances and manage quarantine inventory.
• Process dispositioned material and scrapping of parts from NCRs.
• Approve shipments to sterilization and release sterile products.
• Collaborate with cross-functional teams to resolve non-conformances promptly.

Conocimientos

Quality Assurance

English/Spanish bilingual

Communication skills

Team collaboration

Problem solving

Microsoft Office

Educación

High School Diploma

Bachelor’s degree

Herramientas

ERP Systems

Windows OS

Quality documentation systems

Descripción del empleo

• Ways of Working: Onsite - This job is fully onsite.
• Employee Type: Employee
• Global Job Level (HCM): Support 3 (3)

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 Associate 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.

• 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
  • 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.
• 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.

Qualifications

Required Skills and Experience

• Typically requires a minimum of 2 years of relevant experience requiredin Product Quality role within a medical device company (Preferred).
• 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.