670 empleos en Mexicali, Baja California

Product Release Associate

Intuitive Surgical, S. de R.L de C.V.

Skills, Experience, Education, & Training: ·       High School, Technical Diploma or Bachelor’s degree. ·       8 months to 1 year relevant experience in QA/QC role within a medical device company. ·       Ability to read English, read and comprehend instructions, write short correspondences and memos, complete quality documentation in English and Spanish, effectively present information in one on one and small group situations involving employees, supervisors or engineers. ·       Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements. ·       Demonstrated ability to be a quick learner and understand complex products and processes. ·       Exceptional analytical, problem-solving, and root-cause analysis skills. ·       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. ·       Availability to work on different Shifts as needed. ·       Demonstrated interest in Medical devices, anatomy, surgery and the medical field. ·       Experience with Agile/ACCS and SAP or other electronic documentation systems. English 70%

Hace unos segundos en Mexicali

Regulatory, Post Market Surveillance Analyst

Intuitive Surgical, S. de R.L de C.V.

Education: degree in engineering, life science, or equivalent Experience: 2+ years of experience in medical device field. English 90% (mandatory) Working knowledge and understanding with Medical Device Complaint files and quality record documentation Working knowledge and understanding of Regulatory reporting requirements for Medical Devices (US FDA requirements, EU MDD requirements, etc.). Skills: The following skills are required for this position: Demonstrate strong written and verbal communication skills Strong computer skills (Excel, Word, PowerPoint, database) Efficient independent worker with ability to focus Attention to detail Demonstrate cross functional communication skills in email and in person Excellent organizational and analytical skills Ability to handle and manage workload independently Prioritize numerous activities in a rapid paced environment Contribute to team-oriented tasks Strong analytical skills Strong interpersonal and decision-making skills Competency / Training: The following competencies are essential for this position: Firm understanding of Regulatory reporting requirements for Medical Devices and complaint system and process requirements. Firm understanding of quality records requirements and how they apply to complaint files. Familiarity with world-wide regulatory reporting requirements. Able to make decisions quickly using information at hand and evaluate the need to obtain clarification and direction when necessary.

Hace unos segundos en Mexicali