Product Release Associate

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 Quality Assurance Product Release Associate is responsible for reviewing ION product line’s Device History Records (DHRs) 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 the team lead, 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:

• Reviews DHRs in SAP for compliance to product specifications and company traceability requirements, authorizing release of product for distribution to customers and New Product Introduction (NPI) launches.
• Recording of defects and coordination of the rework of rejected products with the responsible departments.
• Blocking and releasing of products and initiation of necessary corrective actions including effectiveness testing in coordination with the responsible persons.
• Ensures that any non-conformances or deviations are properly approved and documented in the DHR.
• Performs SAP transactions and ensures that released products are transacted in a timely manner.
• Works collaboratively with internal customers to resolve DHR issues in a timely manner.
• Reports on workload status regularly within the team and identifies issues which pose a potential risk to team goals.
• Regular communication exchange with related departments and represents the team in cross-functional meetings.
• Participation in the preparation of statistics and (test) instructions.
• Participates in projects or other activities as directed by management.
• Compliance with the current QMS, DOPs, SOPs, and the safety regulations.
• Perform other duties as assigned.

Qualifications

Qualifications:

• 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 process has been maintained. Demonstrates ability to execute competently and consistently to fundamental job skills while advancing knowledge in more complex disciplines.
• 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.
• Initiative & Follow-through: Seeks opportunities to improve departmental process and expand personal contributions.
• 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.
• Demonstrates ability to execute competently and consistently to fundamental job skills while advancing knowledge in more complex disciplines.
• Skilled at making use of visual aides to convey complex concepts to diverse audiences.
• Minimum 2+ years of operational experience in a Product Quality or certified (e.g. FDA, ISO, Mil-Spec, etc) manufacturing environment.
• Exceptional analytical, problem-solving, and root-cause analysis skills.
• General familiarity with spreadsheet, word processing, and email software.
• Work in an organized and methodical manner, have a high implementation orientation as well as a pronounced awareness of quality and quality processes.
• Even with an increased workload, you work in a structured, thorough and independent manner.
• Very good interpersonal skills.
• Understanding of, or aptitude to understand, Medical Device QMS and regulatory requirements including, but not limited to, ISO13485 and U.S. FDA 21CFR820.

Additional Information

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:$67,200 - $90,900
Base Salary Range Region 2: $57,100 - $77,300
Shift: Day
Travel: 10% of the time
Workplace Type: Onsite - This job is fully onsite.