QA Specialist, Brazil

Company: Intuitive
Location: Sunnyvale
Posted on: May 13, 2022

Job Description:

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 theirmost 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 Position's Objective & Summary: The Quality Specialist for Latin America will support the Brazilian Office maintenaning the Quality Management System (QMS) and execute administrative activities Roles and Responsibilities: Main activities · Maintain the Quality Management System (QMS) assuring: - Oversee the Intuitive Sao Paulo office and ensure all requirements by Anvisa and Intuitive are met - Keep operational licenses updated - Harmonization between local and corporate procedures - Adequate implementation of the procedures (ECO)- Training control - Periodic review of the procedures - Execution of the activities established on the QMS procedures, like CAPA, Management Review, Purchasing, Supplier Controls, Special Labeling and Internal & External Audits as needed - Assist Post Market Surveillance processes such as complaint review, investigation and reporting decisions - Assist with Field Safety Corrective Action process such as distributor notifications and follow ups - ANVISA report for National and Worldwide Adverse Events and Field Safety Corrective Action - Act as a backup for the "Technical Responsible Person" (TRP) and sign documentation as such as needed. · Administrative activities - Being present in the office on a daily basis - Collecting documentation and mail and alerting the appropriate Intuitive contact(s)- Assisting in the coordination of onsite meetings - Assists and supports other employees, teams and field personnel as necessary - Manage pest control and janitorial services - Control inventory and purchase office and cafeteria supplies Qualifications Required Knowledge, Skills, and Experience : · Fluent in written and spoken English is required · Working knowledge of Anvisa requirements · 2-3 years of experience in quality processes of a medical device company · Graduated in Biomedicine, Pharmacy, Nursing or any other life sciences acceptable to be Technical Responsible Person · Demonstrate good interpersonal skills and the ability to work with others in an international team environment with effective interactions in cross departmental teams · Ability to work autonomously, exercise daily judgment based on above experience and knowledge · Focus on accuracy and completeness · General Computer literacy (PC, Microsoft Word/Excel/PowerPoint, Outlook) Additional Information All your information will be kept confidential according to EEO guidelines. 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. Shift : Day Travel : 10% of the time Travel Requirements:10% of the time Shift:Day

Keywords: Intuitive, Sunnyvale , QA Specialist, Brazil, Other , Sunnyvale, California