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Quality Systems Engineer (100% Remote) W2 Only
- 1 year contract opportunity - W2 (No C2C)
- Compensation: $40 - $60/hr
- 100% Remote
Intuitive Surgical, in cooperation with our recruitment partner Raise, are hiring. At Intuitive, 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 in robotic-assisted surgery (RAS), we have been expanding our innovations through technology to help make a difference in the world. For 25 years, human ingenuity has guided our journey to help solve some of healthcare’s most complex challenges.
Join us in making big leaps forward for healthcare professionals and their patients. Together, let’s help to advance the world of minimally invasive care.
Primary Function of Position:
The Digital Engineering Group designs, builds, deploys, and supports both medical device and non-medical device software, data infrastructure, web portals, hardware, web applications and services to collect and analyze medical device machine data from thousands of systems deployed world-wide.
The ideal candidate for the position of Quality Systems Engineer – Digital NMD will have experience in the development, implementation, and support of an effective Quality Management System. This position will be directly responsible for design and development of quality system processes and procedures, as well as enhancement and continuous improvement of existing processes. Their work ensures that Quality is built into our products and processes from the outset of design. The Quality Systems Engineer is expected to bring to their role a passion for Quality Systems, a strong sense of pride in their work output, and a real interest in Intuitive Surgical’s technology, products, and application.
Roles & Responsibilities:
This position has responsibility and authority for:
- Development, implementation, maintenance, and improvements to compliance of applicable regulatory requirements by maintaining an effective quality management system under ISO 9001
- Support audits by the Notified Body and / or other regulatory bodies and third parties, and coordinates responses to applicable audit findings
- Provide support to internal functions in the application, maintenance and improvement of quality systems, procedures, and department specific processes.
- Provides maintenance and administration of Quality Systems tools.
- Prepare quality/performance reports and metrics for the QMS.
- Ensure efficient and effective processes and tools are established for compliance with ISO and other standards and requirements.
- Coordinate the communication and review of quality data in Management Review and other forums.
- Must be able to work with Product development teams, Operations, SQA, Manufacturing, and support groups at all levels.
Skills, Experience, Education, & Training:
Competency Requirements: (Competency is based on: education, training, skills and experience. In order to adequately perform the responsibilities of this position the individual must have:
- Bachelor’s degree in General Business, Engineering, Science a related field or 3-5 years of related experience
- Ability to lead various activities and recommend process improvement opportunities for multiple concurrent projects.
- Experience and knowledge in ISO 9001 and/or ISO 13485
- Able to multi-task in a dynamic, fast-paced environment
- Strong commitment to quality and ability to work closely and communicate effectively with developers and project managers across multiple teams.
- Demonstrated knowledge across multiple aspects of quality systems and quality engineering.
- Experience developing / writing Quality Systems policies, procedures, and training.
- Experience in use and administration of electronic Quality Systems or Product Lifecycle Management tools.
- Strong interpersonal skills and able to work with various cross functional teams to deliver high quality products.
- Attention to detail and organizational skills.
- Excellent communication (written, verbal and presentation) skills, and advanced problem-solving orientation and decision-making skills.
- Excellent documentation skills and ability to communicate effectively at all levels of the organization.
- Possess time management, prioritization skills and ability to perform project work breakdowns and project plans.
- Eligibility to legally work in the United States
We are an AA/EEO/Veterans/Disabled employer.
Please note that this is a contract role providing services to Intuitive through our direct sourcing partner, Raise 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.
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