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 (ISOCFR820); 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 Sites 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 NCs or CAPAs 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.

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 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 Bachelors 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

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.

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.

Remote Work :

No

Employment Type :

Full-time