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 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.
Roles & Responsibilities:
- Reviews and approves manufacturing Device History Records for all assembly levels, ensuring compliance with device master records and other Quality System requirements.
- Releases ISI products, including Instruments and Accessories for distribution according to the stablished procedures.
- Reviews and approves shipments of Single Use Devices to the sterilization process with the sterilizer contractor.
- Reviews, approves and releases sterile products from Intuitive or from a Contract Manufacturer.
- Documents non-conformances through the corresponding quality notification (NCR, VR, DN) on ISI electronic documentation system.
- Works collaboratively with internal and external customers to resolve non-conformances on a timely manner.
- 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.
Supports internal and external audits as required
Skills, Experience, Education, & Training:
- High School, Technical Diploma or Bachelor’s degree.
- 8 months to 1 year relevant experience in QA/QC role within a medical device company (Preferred).
- Ability to read English, 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.
- Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements.
- Demonstrated ability to be a quick learner and understand complex products and processes.
- Exceptional analytical, problem-solving, and root-cause analysis skills.
- 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.
- Very strong computer skills and experience with Windows operating system and Microsoft Office.
- Ability to travel domestically and internationally.
- Availability to work on different Shifts as needed.
- Demonstrated interest in Medical devices, anatomy, surgery and the medical field.
- Experience with Agile/ACCS and SAP or other electronic documentation systems.
- English Level B1 – B2.
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.
