Quality Assurance Associate Job Vacancy in Intuitive Bengaluru, Karnataka – Latest Jobs in Bengaluru, Karnataka

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Company Name : Intuitive
Location : Bengaluru, Karnataka
Position : Quality Assurance Associate

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
Quality System management support & coordination, Complaint Handling, Adverse Event reporting & Field Safety Corrective Actions, Regulatory operations, regulatory registrations/filings,
Roles & Responsibilities:
Main activitiesAssist in the maintenance of Quality Management System ISO 13485 and other applicable regulations under direction of Director, Regulatory Affairs Quality Assurance.Supports in development and review of company procedures, processes and documentation to meet the required guidelines for maintaining compliance to the Quality Management System,Executes /Implements and supports Quality Management System activities such as Complaint handling, documentation, Non-conformance, CAPA, training, management review, auditCoordinates with all process owners to develop procedures as required and implements them.Supports training management through ISU, training curricula development, change management, and as requiredCoordinates complaint reporting and adverse event reporting for India Maintain complaint and nonconformance processing through records and tracking systems, including root cause and corrective actionsDocument quality assurance activities with internal reporting and auditsCoordinate investigations on non-conformances and customer complaint close out and corrective actionsSupports Audit on-going vendors, systems and documents to assure quality assurance compliance with regard to all internal procedures as well as regulatory guidelinesCoordinates execution of Field Safety Corrective Actions in IndiaAssist in carrying out internal quality audits on company systems and documentationsCollaborates with all functional areas of the business to disseminate QMS best practice throughout the organizationEnsure the timely and effective follow up to all identified or assigned quality issuesproper maintenance of control documents in Quality AssuranceSupports the Regulatory Affairs function by ensuring compliance of activities with current internal and external requirements
Additional activitiesActs independently to determine and coordinate methods and procedures on new assignments and works in teams to install or improve related processesAssists and supports other employees, teams and field personnel as necessaryPerforms other tasks and manages projects as assigned
Qualifications
Required Knowledge, Skills, and Experience:
A Bachelor’s or Master’s degree in medical technology, life sciences or similar (or equivalent work experience in similar function)3-5 years of significant experience in Medical Device Industry in similar roleAbility to handle multiple tasks and to prioritize and schedule work to meet reporting or other deadlinesFluent in written and spoken EnglishComputer literacy (PC, Microsoft Word/Excel/PowerPoint, Outlook), experience with Agile, CRM and SAP a plusExcellent interpersonal skills, ability to work with customers and authorities
Preferred Knowledge, Skills, and Experience:
Good knowledge and experience of the QMS systems, ISO13485, Indian Regulatory environment and process for Medical devices, more specificallyKnowledge / broad understanding of what it takes to work in a regulated environment, Environment regulations and other related regulationsAbility to exercise independent judgment and discretion within a broadly defined range of policies and practicesDemonstrated organizational and planning skills, including action oriented, focused urgency and driving for resultsAbility to be effective in complex projects with ambiguity and/or rapid changeGood team skills with ability to collaborate, influence and lead othersOrientation for detail work product, with emphasis on accuracy and completenes

Additional Information
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 : None
Travel Requirements:None Shift:Day

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