Quality Sustaining Engineer I - Shift B

Quality Sustaining Engineer I - Shift B

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

Ensuring Quality process regulations are in compliance with the Quality Management System in the production floor in order to customer standards in the manufacturing process..

MAJOR RESPONSIBILITIES

1. Coordinate with the inspectors on export requirements for OTD compliance.
2. Ensure compliance with GMP regulations, product manufacturing, and customer specifications when manufacturing product
3. Generate and complete tasks corresponding to generated nonconformities.
4. Lead the corresponding core teams and working groups, defining corrective actions for compliance with product specifications
5. Promote improvement projects to increase efficiency and continuous improvement of the area.
6. Audits of Calibrated Instruments used in Quality process and warehouse On Hold of the Area.
7. Perform metrics corresponding to Quality Score Card Process, KPI and Management Review.

Education        

•  Bachelor’s degree with a Bus Business Administration, business or Industrial Engineering.

Knowledge and skills

• Proficient in using SAP
• Root cause analysis knowledge.
• Advanced English level (verbal and writing)
• Teamwork with other departments
• Knowledge of troubleshooting tools
• Good personal relationships
• Attention to details

Experience      

• 0-3 years of experience in manufacturing industry
• Experience in medical industry preferred
• Certified on ISO 13485:20 and/or 9001:2015 standards. 
• Use of Microsoft Office.