Company Description
Descripción de la empresa
En Intuitive, estamos unidos detrás de nuestra misión: creemos que la atención mínimamente invasiva es la atención que mejora la vida. Mediante la inventiva y la tecnología inteligente, ampliamos el potencial de los médicos para curar sin limitaciones.
Como pioneros y líderes del mercado en cirugía robótica, nos esforzamos por fomentar un equipo inclusivo y diverso, comprometido con marcar la diferencia. Durante más de 25 años, hemos trabajado con hospitales y equipos de atención de todo el mundo para ayudar a resolver algunos de los desafíos más difíciles de la atención médica y avanzar en lo que es posible.
Intuitive se ha construido gracias a los esfuerzos de grandes personas de diversos orígenes. Creemos que las grandes ideas pueden provenir de cualquier lugar: nos esforzamos por fomentar una cultura inclusiva basada en la diversidad de pensamientos y en el respeto mutuo. Lideramos con inclusión y capacitamos a los miembros de nuestro equipo para que trabajen de la mejor manera y manifiesten su auténtica personalidad.
Las personas apasionadas que quieren marcar la diferencia impulsan nuestra cultura: los miembros de nuestro equipo se basan en la integridad, tienen una sólida capacidad para aprender, la energía para hacer las cosas, y aportan experiencias diversas del mundo real para ayudarnos a pensar de nuevas maneras. Invertimos activamente en los miembros de nuestro equipo para apoyar su crecimiento a largo plazo y así poder continuar avanzando en nuestra misión y alcanzar su máximo potencial.
Únase a un equipo comprometido a dar grandes pasos hacia delante para una comunidad global de profesionales de atención médica y sus pacientes. Juntos, avancemos en el mundo de la atención mínimamente invasiva.
Job Description
Primary Function of Position:
Ensure that quality systems, products, and manufacturing processes comply with quality standards by supporting and driving improvements in the organization and in accordance with international industry practices and regulations (ISO 13485, 21CFR820); to meet the objectives, provide support and expertise in corrective and preventive actions (CAPAs) process and system and implementing actions to drive the improvement. S/he will partner with subject matter experts on various corrective and preventive (CAPA) activities in addition to supporting other improvement initiatives. S/he will evolve existing processes/systems to ensure timely escalation identification of product quality and compliance issues 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).
- Participates in the emergency brigades and/or Health and Safety Commission when required.
- 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.
- Report any condition and/or behavior that could represent a safety risk
- Complies with health regulatory and International Standard (ISO13485) requirements, Company and site policies, operating procedures, processes, and task assignments.
- Participate in, or lead, the completion of 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.
- Collaborate with cross-functional teams using various methodologies (e.g., Six Sigma root cause analysis/problem-solving skills).
- Independently investigate, gather data, trends, and perform preliminary analysis.
- Process requests, ensuring owners are assigned and timely responses and approvals are provided in alignment with quality goals.
- Leads meetings and communications for CAPA updates, information, and concerns.
- Responsible for assisting with metrics and reporting in accordance with established procedures.
- Support the team in delivering and overseeing the CAPA training program.
- Assist in initiating, processing, and completing CAPA records in the electronic system.
- Execute and provide on-time completion of Quality Engineering deliverables.
- Provide support and CAPA’s process/system subject matter expertise during audits and inspections.
- Support the review and approval of any documentation required by CAPA deliverables.
- Mentor CAPA teams and colleagues who are beginner-level in CAPA processes and systems.
Qualifications
Required Skills and Experience
- Bilingual – (English / Based site language) - Advanced
- Quality Engineer: Systems, Assurance, or Quality Control – Minimum 5 Years experience
- Have worked in a regulated manufacturing industry: Medical devices, Pharmaceuticals, Aerospace, Automobile, Food, etc. - Minimum 5 Years
- Previous CAPA and/or engineering experience and demonstrated use of quality tools/methodologies. - Minimum 5 Years of work 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
- Critical thinking skills for analyzing risk, use of root cause analysis tools, and technical aptitude to collect and analyze data for determining an improvement strategy
- Expertise in cGMP and CAPA documentation
- Computer skills (advanced Microsoft Office Package and statistical/data analysis and report writing skills)
- Strong verbal/written communication skills (communicating effectively at multiple organizational levels)
- Multi-tasks, prioritizes. and meets deadlines in a timely manner
- Solid interpersonal, organizational, and follow-up skills
- Passionate about making products and processes better
- Demonstrated impactful project management and leadership skills, including the ability to lead multi-departmental project teams and resolve quality-related issues 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.
Preferred Skills
- Knowledge of Process improvement tools and methodologies (Lean, Six Sigma) is preferred. Green or Black Belt Certification in Lean or Six Sigma is a plus
- CAPA Review and Approval
- Project Management experience working in a broader enterprise/cross-division business unit model
Required Education and Training
- Engineering Bachelor’s degree - Preferably in science or healthcare fields.
- ASQ certification: CQE, CQA – Preferred.
- Six Sigma and/or Lean certification or training - Preferred
Additional Information
Intuitive es un empleador que brinda igualdad de oportunidades de empleo. Proporcionamos igualdad de oportunidades de empleo a todos los solicitantes y empleados cualificados, y prohibimos cualquier tipo de discriminación y acoso, independientemente de su raza, sexo, condición de embarazo, orientación sexual, identidad de género, origen nacional, color, edad, religión, condición de veterano protegido o de discapacidad, información genética o cualquier otra condición protegida por las leyes federales, estatales o locales aplicables.
Shift: Day
Travel: 10% of the time
