Intuitive Surgical Careers

Product Release Supervisor

US-CA-Sunnyvale, California
Regulatory and Quality


Job Description

Job: Regulatory and Quality
Primary Location: United States-California-Sunnyvale-US-CA-Sunnyvale
Schedule: Full-time
Requisition ID: 180949

Description

Company Description:

Who is Intuitive Surgical? The numbers tell an amazing story. Learn more about our company.




Joining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as our highest priority.

Primary function of position:

The Product Release Supervisor leads a team of dedicated Quality Operations personnel responsible for reviewing Device History Records (DHRs), providing certification for, and executing release of, finished products for use in customer sales or company engineering needs. The supervisor’s area of responsibility may extend to all department personnel at a given site or those supporting specific business units, potentially at multiple sites, as directed by management.
The Product Release Supervisor maintains a positive team environment that reflects the broader company culture, focusing on cultivating ownership, expertise, transparent communication, superior customer service, and a high quality of work output across the team. She positions the team for success by identifying risks with the potential to affect department commitments and prepares the team to adapt accordingly.

Major Responsibilities:

• Mentors and motivates team members to exceed team goals, developing key performers for future growth by recognizing outstanding performance and providing opportunities for them to take on increasingly challenging responsibilities
• Meets regularly with employees to provide and solicit feedback on topics such as team performance, areas of risk, personal growth and improvement opportunities, etc.
• Identifies training requirements and ensures adequate and timely training of department personnel
• Oversees the work quality of the team and ensures that department operating procedures and work instructions are maintained to ensure compliance to regulatory requirements and company policy
• Takes an active role in the hiring process, screening applicants, coordinating interview teams, and conducting interviews to fill openings on the team
• Administers department leadership duties such as approval of employee timecards, review and authorization of time-off requests, monitoring of department inventory locations, employee performance metrics, and other tasks as directed by management
• Collaborates cross-functionally with other teams to develop team schedules and manages resources to ensure deadlines are met. This includes setting daily targets for work output, managing conflicting priorities across business units, scheduling overtime and making data-based staffing recommendations to management
• Maintains a strong working knowledge of company products and procedures and applies past experience to daily problem-solving activities
• Regularly reports to management on team performance, achievements, and areas of risk
• Leads department process improvement projects or other activities as directed by management

Critical Competencies for Success:

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 process 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.
Effective Communicator: Excellent verbal and written communication skills. Skilled at making use of visual aides to convey complex concepts to diverse audiences.
 
Qualifications

Skill Requirements:

• 5+ years of relevant operational experience in a Product Quality or certified (e.g. ISO) manufacturing environment
• Exceptional analytical, problem-solving, and root-cause analysis skills
• Excellent verbal and written communication
• Demonstrated ability to navigate ethical dilemmas and address problems directly
• General familiarity with spreadsheet, word processing, and email software
• Understanding of, or aptitude to understand, Medical Device QMS and regulatory requirements including, but not limited to, ISO13485 and U.S. FDA 21CFR820

We are an AA/EEO/Veterans/Disabled employer.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
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