Supplier Quality Engineer
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About Heraeus
Solutions from the Heraeus Group provide faster internet, rid water of germs, and keep hearts beating in time. As a broadly diversified and globally leading family-owned technology company, we combine materials expertise and cutting-edge technologies to create products used all over the world with one thing in common: World-class quality.
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
Major Responsibilities
- Coordinate the qualification of components from a new supplier. Evaluates, monitors, and approve new and existing external suppliers based in their qualifications and performance.
- Analyzes incoming material defects and communicates issues to suppliers. Investigate failures related to supplier materials identified either at the incoming inspection or reported by the production floor.
- Assists the generation of component specifications, generates, and maintains incoming inspection procedures and provides input from component quality and manufacturability perspectives. Trains inspectors to these procedures as required.
- Leads the creation of Incoming Inspection Procedures, identifying and analyzing critical to Quality Attributes and the applicable sampling procedures.
- Maintains constant communication with the Planning Department to ensure that materials are inspected and dispositioned on time according to the applicable production schedule.
- Maintenance of quality metrics to meet the goals and the regulatory controls according to quality process.
- Lead action that promotes the implementation of cost savings in the Incoming Quality Area and be aligned with company expectations.
- Support current and future business needs through the development, engagement, motivation, and preservation of human capital.
- Identify and manage the conflicts in the incoming inspection area promoting teamwork, communication, empathy as part of adequate organizational environment.
Education
Bachelor’s degree in Engineering discipline or Business Sciences.
Knowledge and skills
- Specialized knowledge for Incoming Quality Assurance, Supplier Management and related areas.
- Proficient in using Quality Management Systems and ERP solutions.
- Proven experience handling Supplier related issues and supplier changes.
- Demonstrated experience working with manufacturing problem solving related with quality issues.
- Fluent in spoken and written business English and Spanish
- Knowledge of business and management principles involved in strategic planning, resource allocation, human resources modeling, leadership techniques, inspections methods, and coordination of people and resources.
- Proficient with Microsoft Office.
Experience
- 5+ years of experience in related positions including Quality Receiving Inspection, Assurance, Change Control, QMS.
- 4+ years leading work teams of specialized people.
License or certifications required
- ASQ certified Quality engineer or certified Supplier Quality Engineer is a plus.
- ISO 13485:20XX auditor is a plus.
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