Sr Quality Systems Engineer - TMV #9202

• Review TM procedures and update if needed.
• Review TMV protocols for each equipment/measuring instrument that needs validation and update if needed.
• Support the execution of TMVs.
• Perform data analysis of the validation runs, including Repeatability and Reproducibility of variable data (Gage R&R) and Attribute Agreement Analysis for categorical data.
• Prepare TMV reports and support their submission for approval.
• Update Receiving Inspection documents based on validation results.
• Prepare and maintain a Project Tracker with weekly updates for Management Review.

• Bachelor’s Degree in Engineering.
• 10+ year of experience.
• Advanced computer skills including MS Office applications (Word/ Excel/ PowerPoint/ Project/ Visio)
• Proficient in the use of Minitab statistical analysis.
• Experience with SolidWorks, ProE or Inventor, prototypes, 3D (desirable)
• Familiar with electronic management documentation.

ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges, and we take pride in providing them transformative solutions with distinctive, sustainable and long-term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.