- 3 Month contract opportunity - W2 (No C2C)
- Compensation: $35 - $42/hr
- 100% Remote
Intuitive Surgical, in cooperation with our recruitment partner Raise, are hiring. We’re 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 for 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 Regulatory Post Market Surveillance Quality Engineer supports RPMS continuous improvement projects as well as, where needed, complaint investigation and related activities.
Roles & Responsibilities:
This position has responsibility for:
- Supporting a strategic project related to pre-mapping complaint types to the appropriate reference defined within the applicable risk management documentation.
- Supporting a strategic project related to assuring alignment between reportability decisions and the anticipated degree of harm defined within risk management documentation.
- Interfacing across the organization to identify and support continuous process/quality improvement programs that strongly align with Intuitive standards and customer needs while meeting all applicable Medical Device Regulations and Standards. Customer Service and hospitals to gather additional information required for complaint investigation, including retrieval of RMA
- Participate in new hire training and continuous Regulatory Compliance training as required
- Participate in process improvement activities to continuously improve complaint process effectiveness
- Execute on additional projects as required
- Support complaint investigation activities as required
- Perform other duties as directed
Skills, Experience, Education, & Training:
Education - Bachelor's degree (Engineering or equivalent) combined with minimum 3 years of related experience in Quality, Engineering, Operations, or a continuous improvement environment.
Experience – 2+ years of experience in medical device field, with experience or exposure in the following areas:
- Knowledge and understanding with Medical Device Complaint files and quality record documentation.
- Knowledge and understanding of Regulatory reporting requirements for Medical Devices (US FDA requirements, EU MDD requirements, etc.)
- Knowledge and understanding of risk management documentation
- Knowledge and understanding of problem solving methodologies
- General technical and/or clinical knowledge of medical devices
- Experience gathering/processing internal and external requirements.
- Knowledge of Quality Systems Regulations (21 CFR 820) and ISO 13485 preferred.
- Knowledge of Process improvement tools and methodologies (Lean, Six Sigma) is preferred.
- Project Management experience preferred.
Skills: The following skills are required for this position:
- Demonstrate strong written and verbal communication skills:
- Passionate about making products and processes better
- Able to assist people in finding creative solutions around constraints.
- Able to deliver presentations to a broad audience
- Strong computer skills (Excel, Word, PowerPoint, database)
- Efficient independent worker with ability to focus
- Attention to detail
- Demonstrate cross functional communication skills in email and in person
- Excellent organizational and analytical skills
- Ability to handle and manage workload independently
- Prioritize numerous activities in a rapid paced environment
- Contribute to team-oriented tasks
- Strong analytical skills and problem-solving skills
- Strong interpersonal and decision-making skills.
- Demonstrated business knowledge and the ability to display the linkage between projects and desired business results.
- Proven ability to investigate issues and drive creative problem-solving related to product/process issues and effectively document as needed.
- Ability to collaborate effectively with product and/or process subject matter experts in a cross-functional team environment is required.
- Technical aptitude to collect and analyze data for determining an improvement strategy.
- Ability to navigate multiple projects with changing priorities. Ability to execute to project timelines.
Competency / Training: The following competencies are essential for this position:
- General understanding of Regulatory reporting requirements for Medical Devices, complaint system and process requirements.
- General understanding of quality records requirements and how they apply to complaint files.
- Able to make decisions quickly using information at hand and evaluate the need to obtain clarification and direction when necessary.
- Green or Black Belt Certification in Lean or Six Sigma is a plus.
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.
Int22