Senior Quality Engineer (Disposables)

The Quality Engineer will focus on development of Process Validation strategies, non-conformances, MRB, CAPA’s, tracking and reporting on monthly basis and compiling and presenting data for management review, execution, and approvals of change orders.  

Essential Job Functions and Responsibilities 

Core Job

• Manufacturing process sustaining (Cleanroom environment). 
• Sterilization concepts and product release. 
• Contractor´s management, such as external laboratories and sterilization sites. 
• Quality Inspectors management.

Supporting

• NPI’s activities from SJ Facility to MX facility by developing and executing the transfer validation strategy. (IQ, OQ or PQ)
• Change orders for process improvements and determines when process stability and capability studies should be performed on existing processes.
• Analyzes and performs failure analysis to non-conforming products.
• Leads in the implementation of assurances, process controls, nonconformances and CAPA. 
• Reviews and participates in the update/creation process FMEA’s, application FMEA’s, and risk benefit analysis for medical devices.
• Develops and prepares monthly quality trend analysis and reports.

Interpersonal skills

• Leads, coaches, and mentors non-exempt and entry level exempt personnel. 
• A self-starter, motivated and able to positively motivate others.
• Focused, target driven with a positive, can-do attitude.
• Support additional activities, as assigned.