- 6 Month contract opportunity - W2 (No C2C)
- Compensation: $50 - $60/hr
- Hybrid: 5430 Metric Place, Peachtree Corners, 30092
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:
Ensure that quality systems, products, and manufacturing processes comply with quality standards in accordance with international industry practices and regulations (e.g., ISO 13485, 21CFR820). Meet objectives, lead and provide CAPA coordination data analytics and provide clear, professional updates to leadership. S/he will partner with CAPA CIQE team and subject matter experts on various CAPA activities. S/he will help ensure CAPA logs are accurate, CRB meetings are scheduled/coordinated, there is timely CAPA initiation and execution, and review of CAPAs occurs within a closed-loop quality management system.
Roles & Responsibilities:
- Support and comply with Company and Site’s Health, Safety, and Environmental programs and requirements, including:
- Use of personal protective equipment (PPE) as applicable.
- Use devices, accessories, tools, and equipment according to the process, verifying that they are in good condition for use and reporting those that are in poor condition for repair.
- Communicates unsafe acts or conditions to their superiors.
- Participates in the Health, Safety, and Environment courses established.
- Maintains order and cleanliness in the workstation (5S) under responsibility.
- Complies with health regulatory and International Standard (ISO13485) requirements, Company and site policies, operating procedures, processes, and task assignments.
- Participate in and help coordinate CAPA projects, assuring compliance, quality, and timeliness of records.
- Communicate confidently and effectively with all levels of management, peers, and key stakeholders, including timely escalation of quality issues.
- Process requests, ensuring subject matter experts and action item owners are assigned and provide timely responses in alignment with quality goals.
- Execute and provide on-time completion of Quality Engineering or Quality Plan deliverables.
- Schedules and leads meetings and communications for CAPA updates, information, and concerns.
- Responsible for assisting with metrics and reporting in accordance with established procedures.
Skills, Experience, Education, & Training:
- Quality Engineer: Systems, Assurance, or Quality Control – Minimum 4 Years experience
- Have worked in a regulated manufacturing industry: Medical devices, Pharmaceuticals, Aerospace, Automobile, Food, etc. - Minimum 4 Years
- Previous CAPA and/or engineering experience
- Detailed knowledge of Quality System Regulations (21CFR820) and ISO 13485. - Minimum 3 Years
- Ability to work in a highly matrixed and geographically diverse business environment
- Quality/Compliance focus and attention to detail
- Advanced to Expert computer skills (Primary focus- Microsoft Outlook, PowerPoint, and Excel)
- Demonstrated impactful project management skills, including the ability to coordinate multi-departmental project teams in a timely and effective manner
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment
- Ability to leverage and/or engage others to accomplish projects
- Strong verbal/written communication skills with ability to communicate effectively at multiple organizational levels
- Multi-tasks, prioritizes, and meets deadlines in a timely manner
- Strong interpersonal, organizational, and follow-up skills
Required Education and Training
- Engineering Bachelor’s degree - Preferably in science or healthcare fields.
Working Conditions
- Desk and meeting rooms (as applicable)
Preferred Skills and Experience
- ASQ certification : CQE, CQA
- Knowledge of Process improvement tools and methodologies (Lean, Six Sigma) is preferred.
- CAPA performance or coordination (including data analysis and metric reporting)
- Management Review
- Project Management experience
- Experience working in a broader enterprise/cross-division business unit model
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