Senior Quality Engineer

Primary Activities

• Support production through the application of risk management and process controls 

• Provide appropriate levels final inspection 

• Help provide quality engineering expertise to maintain and improve product quality 

• Approve process validation test plans, protocols and reports.  

• Provide approval of design changes 

• Monitor quality metrics and key process indicators 

• Provide appropriate level of part and process qualification 

• Support Continuous Improvement activities  

Skills

• Experience with test methods and standards for the validation 

• Knowledge of ISO 9001 and ISO 13485 standards

• Knowledge in test plan development and root cause failure analysis

• Skilled in quality engineering tools and disciplines 

• Good verbal (including presentation) and written communication skills

• Have the ability to appropriately assess written design, process and device documentation