Intuitive Surgical Careers

DHR Associate

Mexico-Mexicali, Mexico
Manufacturing & Operations


Job Description

Job: Manufacturing & Operations
Primary Location: Mexico-Baja California-Mexico-Mexicali
Schedule: Full-time
Requisition ID: 182736

Description

The Quality Control department is devoted to verifying that manufactured products meet specification and are produced in accordance with all requirements. The Quality Assurance Associate will work with a team of dedicated individuals within Production to assure compliance to of finished product quality system requirements; to identify discrepancies related to traceability, rework, ECO and Deviation implementation, and drive resolution of such discrepancies; and to authorize release of product to customers.
 
The successful candidate will be a team leader within the department, becoming an expert in thorough and accurate device history record review and governing department and standard operating procedures. He or she will become cross-functionally recognized for his or her penchant for identifying discrepancies, strong commitment to compliance, ability to exercise excellent judgment, ability to demonstrate exemplary interpersonal skills, and consistent dedication to delivery against schedule. The candidate must value shared responsibility and celebrate shared success, while forging strong relationships through collaboration with manufacturing leads, planners, supervisors, and the Sunnyvale Quality Control and Quality Assurance departments.
 
Roles & Responsibilities
 
Primary Responsibilities:
DOCUMENT REVIEW & PRODUCT RELEASE
  • Reviews and approves manufacturing device history records, ensuring compliance with device master record and other quality system requirements
  • Provides authorization to release product, including Instruments and Accessories, for distribution to customers
  • Documents non-conformances in ISI electronic documentation system
  • Works collaboratively with internal customers to resolve non-conformances in a timely manner
  • Trains manufacturing personnel to correct documentation practices
  • Maintains department databases and tracking systems as required by management
  • Reports status to management on daily and weekly basis
  • Escalates areas of concern to the Quality Assurance department and direct management
  • Performs all work according to quality standards as set by the Quality Assurance department and direct management
  • Performs all work according to production schedule, including working overtime as required
  • Files and archives paper device history record documents
     
    REPORTING AND PROJECTS
  • Publishes quality and operational metrics to direct management
  • Works on continuous improvement projects with direction from management
     
     
  • Escalating to the Quality Assurance and direct management all quality issues that could impact patient safety, surgical efficacy or traceability
  • Ensuring successful, on-time completion of department projects; communicating constraints to direct management when successful project completion is at risk
  • Compliance with company Department and Standard Operating Procedures
     
Qualifications

Skill & Job Requirements
 
Required:
 
  • Bachelor’s degree
  • 5 years relevant experience in a QA/QC role within a medical device company
  • Excellent command of the English language, in both written and verbal form
  • Demonstrated understanding of or aptitude to understand Medical Device QMS requirements and regulatory requirements including but not limited to FDA 21 CFR 820 and ISO 13485
  • 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
  • Excellent verbal communication and writing skills in the context of reports, business correspondence, procedures
  • 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
  • Very strong computer skills and experience with Windows operating system and Microsoft Office
  • Ability to travel domestically and internationally
     
    Preferred:
  • Demonstrated interest in medical devices, anatomy, surgery, and the medical field
  • Experience with Agile/ACCS and SAP or other electronic documentation systems