Primary Function of Position:
Ensure that manufacturing processes comply with quality standards performing follow-ups and monitoring the notifications generated, process validations and defect trends, in accordance with international industry practices and regulations (ISO 13485, 21 CFR820); to meet the objectives of the quality department, providing support in corrective and preventive actions (CAPAs) and implementing actions that generate defect reduction.
Roles & Responsibilities:
- Prepares trend reports of PLs (Process Log) and Quality Notifications (VRs, NCRs, EEs) performing analysis of major offenders
- Follow up on Quality Notifications (VRs, NCRs, EEs) open for Mexicali and Corporate locations that affect assigned products (PDIA, History Check and Root Cause Analysis) Participates in the development of lines, process and / or products validations documenting their results in SAP or Agile systems
- Conducts improvement projects for defect reduction
- Performs mentoring activities for new quality engineers
- Completes the assigned trainings in ISU (Intuitive Surgical University) curriculum Prepares performance self-assessment for the MERIT process
- Comply with the organization's policies, regulations and Code of Conduct
- Provides feedback clarifying quality controversies to Production Supervisors or FQI Technicians according to regulatory standards
- Participates in Customer Complaint investigations
- Reviews and approves validation protocols documenting their results in SAP or Agile systems
- Performs formal escalation process (Escalation Decision Form) or report nonconforming product, when required
- Follows up on quality problems of recurring raw material
- Participates in the activities of preparation of audits and its development
- Drives our Culture Strategy by fostering our mission, founding principles, individual and leadership expectations.
- Use Personal Protective Equipment
- Participates in the emergency brigades and Health and Safety commission, when required
- Use devices, accessories, tools and equipment according to the process; verifying that they are in good conditions of use and reporting those that are in poor condition for repair
- Communicates unsafe acts or conditions to their superiors
- Participates in the Health and Safety courses established by the company
- Maintains order and cleanliness in the workstation (5s) under your responsibility
Skills, Experience, Education, & Training:
- Bachelor’s Degree in an engineering field
- System management: Microsoft Office Package, SAP System, Minitab desired
- Desired Job or area experience: Quality Engineer or Manufacturing Engineer 5 years
- Experience in process validations 5 years
- Experience in quality audits for medical products 3 years
- Have worked in the medical industry 3 years
- Knowledge/skills: Lean Manufacturing 3 years
- Desired Knowledge in ISO-13485, 21CFR820 3 years
- Troubleshooting techniques (CAPA System, 5 whys, Fish Diagrams, 8 Ds) or similar 3 years Six Sigma and statistical tools (MSA-Measurement System Analysis, DOE-Design of Experiments, Process Capability, SPC-Statistical Process Control, Process and Design FMEA- Failure Mode and Effect Analysis 3 years
Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
Intuitive is an Equal Employment Opportunity Employer. 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 qualified applicants with arrest and conviction records in accordance with fair chance laws.
Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.
We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.
