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.

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
    • 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.

Required Skills and Experience

• Typically requires a minimum of 2 - 4 years of related experience in 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.

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.