Company DescriptionAt 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.
Primary Function of Position:
The Product Release Specialist will work with multidisciplinary teams dedicated within Manufacturing, FQI, Planning and Engineering to assure compliance of finished product to 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 and help with the resolution of such discrepancies to authorize release of products to customers.
Review of device history records (DHRs) entails examination for accuracy and completeness, certifying compliance to product specification and traceability requirements, and ensuring that any deviations from the manufacturing process were properly recorded and authorized by members of the appropriate departments.
The Product Release Associate receives guidance on workload prioritization from their reporting senior but is ultimately responsible for organizing and executing their projects and daily standard workload in a manner which meets the schedules of the operational teams whom they support.
Roles & Responsibilities:
- Review DHRs for systems, instruments, and accessories for compliance to product specifications and company traceability requirements, creating certification documents and authorizing release of product for distribution to customers and New Product Introduction (NPI) launches as applicable.
- Performs inventory transactions and ensures that released products are transacted in a timely manner to maintain inventory accuracy for department inventory locations.
- 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 in 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.
- Complies with company department and standard operation procedures.
- Supports internal and external audits as required.
- Solve minor concerns about the procedures of their colleagues and members of other departments.
- Coordinates transfers of non-conforming material between plants.
- Provides support to Manufacturing Engineers during PPQ’s.
- Lead small and medium improvement projects for the department.
- Ensuring successful, on-time completion of department projects; communication of constraints to direct management when successful project completion is at risk.
- Publishes Quality and Operational metrics to direct management.
- Team-Oriented: Approaches their work selflessly and without ego, making an honest effort to manage their own assigned workload, communicating openly and in a timely manner when deliverables are at risk, and actively seeking opportunities to ask, "How can I help?" Freely shares information and makes it a priority to mentor their peers when the opportunity presents itself.
- Quick Study & Continuous Learner: Demonstrates aptitude for learning new processes quickly, actively seeks deeper understanding of processes and functions critical to their role. Strives to understand the bigger picture and how their role supports key company objectives.
- Perceptive & Detail Oriented: Skilled at sensing variations from the norm and thoroughly investigating whether compliance to company processes has been maintained. Demonstrates ability to execute competently and consistently to fundamental job skills while advancing knowledge in more complex disciplines.
- Initiative & Follow-through: Seeks opportunities to improve departmental process and expand personal contributions. Can be relied upon to complete commitments without excessive follow-up.
- Good Judgment: Strong ability to draw correlations to prior experience and identify precedent in ambiguous circumstances. Demonstrated track record of making good decisions.
- Ethical & Independent: Demonstrates recognition of the criticality of the job function and strives to conduct themselves in a manner which does not invite doubt about their ability to consistently execute process without direct supervision. Does not cut corners or bow to external pressure to compromise on requirements.
- Integrity: Accepting and adhering to high ethical, moral, and personal values in decisions, communications, actions and when dealing with others.
Skills, Experience, Education, & Training:
- Minimum 2+ years of operational experience in a Product Quality or certified (e.g., FDA, ISO, Mil-Spec, etc.) manufacturing environment or 1-year relevant experience as Product Release Associate.
- Minimum education: Technical Diploma or Bachelor’s degree preferred.
- Ability to read English, read and comprehend instructions, write short correspondences and memos, complete quality documentation in English, effectively present information in one on one and small group situations involving employees, supervisors, or engineers.
- Exceptional analytical, problem-solving, and root-cause analysis skills.
- 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.
- Experience with Agile/ACCS and SAP or other electronic documentation systems.
- Understanding of, or aptitude to understand, Medical Device QMS and regulatory requirements including, but not limited to, ISO13485 and U.S. FDA 21CFR820
Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.
We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.
Base Salary Range Region 1: $59,500 USD - $80,500 USD
Base Salary Range Region 2: $50,600 USD - $68,400 USD
Travel: 10% of the time
Workplace Type: Onsite - This job is fully onsite.