Quality System CAPA Specialist

Work location: Remote or onsite at any ISI location

We’re Intuitive: a global technology leader in minimally invasive care and a pioneer of robotic-assisted surgery. Working closely with hospital teams, we’re developing integrated solutions that help enable physicians to get patients back to what matters most. Our technology has been used in nearly 10 million operations across 67 countries.

Together, we’ve dedicated more than two decades to innovating for better care through enhanced experiences, improved efficiencies, and reduced cost of care. In this role, you will join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients.

Primary Function of Position:

The Quality System CAPA Specialist implements and efficiently executes Quality System tasks related to the CAPA program at Intuitive, ensuring ongoing compliance with internal processes.

This individual ensures effective completion of all tasks, by seeking and incorporating cross-functional input.

Roles & Responsibilities:

• Coordinates the execution of CAPA tasks from initiation to completion. Responsible for management of task completion and timelines related to assigned tasks to meet CAPA objectives.
• Applies Quality Systems knowledge when executing assigned tasks
• Assesses Quality System procedures and ensures that all required functional approvers and responsibilities are established in accordance with the specific process and regulations
• Creates and updates Quality System procedures as required
• Acts as a CAPA Team member and works with the CAPA Owners to ensure tasks are complete
• Provides regular status of assigned tasks during review meetings.
• Works with team and required functions to collect input for the assigned tasks
• Executes and completes other assigned tasks

Skills, Experience, Education, & Training:

• Bachelor’s degree in Business and 3 years of experience in a Quality Systems related field.
• Applied understanding of CGMPs, CFR 820, ISO 13485
• Intermediate level knowledge of Quality Systems and Change Control
• Experience in the Quality System CAPA process
• Strong technical writing skills to support authoring of Quality System procedures
• Previous experience with medical devices in an FDA-regulated environment.
• Experience with Agile or similar change management software (preferable)

You will have:

• Highly developed interpersonal skills, with a strong ability to lead internal and external resources, and build commitments
• Demonstrated ability to communicate effectively with people at all levels, from individual contributors to executive leadership.
• Ability to work well in a fast-paced environment
• Strong organizational, written, and verbal communication skills and the proven ability to prioritize tasks effectively in a deadline-driven environment

Please note that this is a contract role providing services to Intuitive through our direct sourcing partner, Raise Recruiting, who manages Intuitive’s Contractor Talent Community. If you are selected for this role, you will be employed by Raise and will not be an employee of Intuitive.

Work with an Award-Winning Employer:

●      Best Places to Work, Glassdoor Employees’ Choice, 2019 (#12 of 100), 2020 (#7 of 100)

●      America’s Best Midsized Employers, Forbes, 2019 (#149 of 500)

●      Top 150 Places to Work in Healthcare, Becker’s Hospital Review, 2019

●      Top CEOs, Glassdoor, 2019 (#9 of 100)

Raise and Intuitive are Equal Employment Opportunity Employers. 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 all qualified applicants with arrest and conviction records in accordance with fair chance laws.