Sr. Quality Engineer

Sr. Quality Engineer

Permanent 

 

 

About Heraeus

Making displays foldable? Helping hearts beat with medical innovations? Or breathing new life into precious metals? As a family-owned global technology group we help our customers to always being one step ahead.

About Heraeus Medevio

Together we improve lives. At Heraeus Medevio, we bring lifesaving and life-changing medical devices to market through partnerships with medical device manufacturing companies. Backed by Heraeus Group, we are committed to the growth of our teams and organization by providing an open space for open minds.

To reach our vision of improving 100 million lives every year, we foster a culture of curiosity that thrives on challenge, continuous learning, growth, and the opportunity to try new things. With sites in the United States, European Union, and Asia, and over 2,200 employees worldwide, together, we will meet tomorrow's challenges today.

 

Job Purpose

Assuring customer’s specifications and quality standards are comply during the manufacturing process according to the quality management system of Heraeus Medical Components

Required Qualifications:

• Bachelor’s degree in engineering discipline or business sciences
• 8-10 years in similar position, 5 years in medical company

Skills & Knowledge:

• Understanding of root cause analysis, statistical analysis, and SPC
• Nonconformance and customer complaint escalation, trend analysis, disposition, investigation, and corrective/preventive actions
• Strong critical thinking and communication skills
• Knowledge and understanding of ISO 13485:2016 requirements and other applicable regulations
• Fluent in spoken and written business English and Spanish

Preferred Qualifications:

• ASQ certified Quality engineer a plus
• Master Degree in science or medical device fields
• Six Sigma Tools and Geometric Dimensioning and Tolerancing experience
• Process validation