Responsibilities

• Coordinate projects Globally for multi-site locations from the Corporate Headquarters.


• Participate on cross-functional new product development teams with focus on the execution of quality plans and design transfer. 


• Develop and implement statistically valid sampling plans, designed experiments, capability studies, SPC and trend analysis. 


• Lead and/or participate in process and product corrective actions and problem-solving activities. 


• Review the current quality system and recommend / implement improvements as needed. 


• Review collected data to perform statistical analysis and recommend process / product changes to improve quality.


• Lead projects focused on to quality system, product quality and service quality improvement. 


• Report on the performance of the quality system. 


• Participate in strategic planning and audits of internal and supplier quality systems. 


• Participate/support external and internal quality system audits.

Requirements

• Bachelor's Degree in Engineering or related technical field required.

• 5+ years of combined Manufacturing/Quality Engineering and/or Quality Systems experience.


• Experience with medical device or other regulated industries preferred – Other regulated industries would be considered…Pharmaceutical, Aerospace, Automotive, Food & Beverage.


• Experience working in an ISO certified environment required….ISO 13485 is ideal.


• Focus on identification of potential issues and continuous improvement.


• Experience working on cross-functional teams and on own initiative.