Sr. Continuous Improvement Quality Engineer

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 NC & 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 NC & 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 NC/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 NC & CAPA training program.

• Assist in initiating, processing, and completing NC & CAPA records in the electronic system.

• Execute and provide on-time completion of Quality Engineering deliverables.

• Provide support and NC’s or CAPA’s process/system subject matter expertise during audits and inspections.

• Support the review and approval of any documentation required by NC/CAPA deliverables.

• Mentor NC/CAPA teams and colleagues who are beginner-level in NC/CAPA processes and systems.

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 NC & 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 4 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 NC/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

• NC & 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

Working Conditions

• Desk and meeting rooms

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.

Aviso sobre los Controles de Exportación de EE. UU.: De acuerdo con las Regulaciones de Administración de Exportaciones de EE. UU. (15 CFR §743.13(b)), algunos puestos en Intuitive Surgical pueden estar sujetos a controles de exportación de EE. UU. para candidatos que sean nacionales de países actualmente bajo embargo o sanciones.

Cierta información que usted proporcione como parte de la solicitud será utilizada para determinar si Intuitive Surgical necesitará (i) obtener una licencia de exportación del gobierno de EE. UU. en su nombre (nota: el proceso de obtención de la licencia puede tardar entre 3 y más de 6 meses) o (ii) implementar un Plan de Control de Tecnología (“TCP”, por sus siglas en inglés) (nota: normalmente este paso agrega 2 semanas al proceso de contratación).
Para cualquier puesto en Intuitive sujeto a controles de exportación, las ofertas finales están condicionadas a la obtención de una licencia de exportación aprobada y/o a la ejecución de un TCP antes de la fecha de inicio del empleado potencial, la cual puede o no ser flexible, y dentro de un plazo que no obstaculice de manera irrazonable la necesidad de contratación. Si aplica, los candidatos serán notificados e instruidos sobre cualquier requisito relacionado con estos fines.