Company Description
At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.
As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.
Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves
Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.
Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.
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 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.
• Performs the following process as necessary:
o Review and release of ISI products, including Instruments, Accessories and Endoscopes (Refurbish) for distribution according to the stablished procedures.
o Review and approve of shipments of Single Use Devices to the sterilization process with the sterilization contractors.
o Review, approve and release of sterile products manufactured by Intuitive or from a Contract Manufacturer.
• Documents non-conformances through the corresponding quality notification (NCR, VR, DN) on ISI electronic documentation system.
• Handling and storage of non-conforming inventory in the quarantine areas, performing cycle counts and delivering products to manufacturing operations for sorting or rework.
• 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.
Qualifications
Skills, Experience, Education, & Training:
- High School, Technical Diploma or Bachelor’s degree.
- 6 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.
- 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).
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.