Quality Assistant

at  Mammotome

Mammotome associates know that every moment matters when it comes to advancing breast cancer diagnostics and surgical solutions. When you come to work at Mammotome, you’re collaborating with a global team of engineers, designers, communicators, strategists, and specialists to improve patient outcomes. If you want to be inspired to grow every day, join our diverse, hardworking, high-performing team.
Be part of a company that’s a trusted leader in breast cancer diagnostics and support products you can feel passionate about!
Mammotome is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges.
The Quality Assistant for Mammotome is responsible for applicable documentation management functions to ensure proper release of subassembly and/or final product for sterilization or sale; detect any deviations or non-conformances in the device history record.
This position is part of the QA team located in Tijuana, Baja California, Mexico and will be on-site. At Mammotome, our passion is driving innovative technologies that create efficiencies, while never forgetting that at the heart of every breast cancer journey is a patient.

THE ESSENTIAL REQUIREMENTS OF THE JOB INCLUDE:

• 1 to 3 Years within a similar role or manufacturing environment.
• Knowledge of MS Office, Outlook, Quality Systems and Good Manufacturing Practices .
• Knowledge in ISO 13485, FDA standards and regulations and SAP (Desirable)

IT WOULD BE A PLUS IF YOU ALSO POSSESS PREVIOUS EXPERIENCE IN:

• Communication and Leadership Skills: Basic English (Comprehends Simple Oral or Written instructions)
• Travel Requirement: None
• Communication and Leadership Skills: Basic English (Comprehends Simple Oral or Written instructions)
  Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
  For more information, visit www.danaher.com.
  At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

• Release in system of finished product, Pouch, FG and regular product shipments (Hydro, import and export), evaluate release procedures and forms for adequacy and establish daily communication through email reporting lot status.
• Compile all the device history records, scan and archive all device history records.
• Maintain release cycle time to support customer service activities and metrics related to the release activities such as release cycle time and Acceptance rate.