Quality Sustaining Engineer II

Quality Sustaining Engineer II

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 meet customer standards in the manufacturing process.

Major Responsibilities

List statements describing the results of this position and method of accomplishments, and how results/performance are reviewed and measured.  Begin with the most important accountabilities.  Try it by processes and ordering from highest to lowest percentage of time.

Major responsibilities

• Coordinate with the inspectors on shipment requirements for OTD and Revenue compliance.

• Ensure compliance with Quality regulations, product manufacturing, and customer specifications when manufacturing product.

• Generate and complete tasks corresponding to Sustaining Non-Conformities and CAPA investigations.

• Lead the corresponding core teams and working groups, defining corrective actions for compliance with product specifications

• Promote improvement projects to increase efficiency and continuous improvement of the area.

• Support Quality Engineering initiatives to improve QMS tools such as SPC, Problem-Solving, Preventive Quality, providing technical support to get high-quality standards.

• Drive statistical analysis and tools like DOE and Minitab to identify quality issues trends and improve processes.

• Perform metrics corresponding to Quality Score Card Process, KPI and Management Review.

Knowledge, Skills and Abilities

• Bachelor’s degree with an Engineering or Business Administration grade.
• Proficient in using in ERP systems like SAP.
• Root cause analysis knowledge
• Fluent in spoken and written Business English and Spanish
• Teamwork with other departments
• Knowledge of troubleshooting tools
• Good personal relationships
• Attention to details
• 3-5 years of experience at Quality Sustaining or similar roles in manufacturing industry
• +2 years at medical devices industry
• Certified on ISO 13485:20 and/or 9001:2015 standards. 
• Use of statistical and Quality tools as Minitab, DOE, SPC, ANOVA, Problem-Solving, among others.}
• Certified on ISO 13485:2016 and/or 9001:2015 standards.