Intuitive Surgical Careers

Quality Control Engineer

Mexico-Mexicali, Mexico
Manufacturing & Operations


Job Description

Job: Manufacturing & Operations
Primary Location: Mexico-Baja California-Mexico-Mexicali
Schedule: Full-time
Requisition ID: 183638

Description

Joining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as our highest priority.
 
The Quality Assurance department is devoted to assuring safe, reliable and effective products that exceed patient, surgeon and hospital expectations. The department plays a vital role in product and process quality supporting commercial production for all da Vinci™ Surgical System product lines including system platforms, endoscopic instrumentation and supporting accessories.
 
The Quality Control Engineer (QCE) works with a team of dedicated individuals supporting manufacturing operations to assure quality of finished product and identify quality issues related to electrical, mechanical and software subsystems. The QCE evaluates product quality issues, performs root cause analysis, identifies remedial actions and follows up to ensure all actions are completed satisfactorily prior to resolution and closure.

Roles & Responsibilities
PROCESS DEVELOPMENT
 
  • Develops and validates quality assurance procedures, sampling plans, methods, equipment and processes
  • Monitors manufacturing procedures, processes and records for compliance with established requirements
  • Evaluates deviations and non-conformances and supports resolution of quality issues
  • Supports process validation and verification
  • Reviews and trends product and process quality issues using data analysis and root cause investigation
  • Responds to quality escalations and provides technical support for troubleshooting and testing
  • Perform risk analysis and determines quality disposition for variance requests and non-conformances
  • Represents the department cross-functionally in meetings that may include senior and external personnel
  • Releases process and document changes through engineering change orders and deviations using ISI change control process
  • Escalates to direct management all quality issues that could impact patient safety or surgical efficacy
  • Ensures successful, on-time completion of department projects, communicates constraints to direct management when successful project completion is at risk
  • Performs other duties as assigned by management


     


Qualifications

Required:
  • English Level: High
  • Demonstrated interest in medical devices, and the medical field
  • Bachelor’s degree in Engineering or Life Sciences
  • 3+ years of relevant QA experience or the following:
    • Demonstrated understanding of and ability to perform the Quality Control Engineering function at ISI, while executing routine work with little to no supervision, working on with minimal instruction, identifying issues independently, and proposing viable solutions
  • Demonstrated understanding of Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485
  • Understanding of document change control, process verification and validation methodologies, production process control methodologies in a medical device environment
  • Previous work experience with product / process verification and validation, as well as production process controls methodologies in an FDA/ISO regulated environment
  • Demonstrated ability to be a quick learner and understand complex products and processes
  • Exceptional analytical, problem-solving, and root-cause analysis skills
  • Change agent with energy, passion, and enthusiasm to drive change
  • Integrity: Accepting and adhering to high ethical, moral, and personal values in decisions, communications, actions, and when dealing with others
  • Demonstrated ability to work independently and with minimal supervision, multi-task, and handle tasks with competing priorities effectively
  • Strong computer skills and experience with Windows operating system and Microsoft Office
  • Ability to travel domestically and internationally
 
Preferred:
  • 3+ years relevant experience in a medical device company
  • Experience with Agile/ACCS and SAP or other electronic documentation systems
  • Participation in internal /external audits conducted
  • Work experience with highly complicated electro mechanical devices