Quality Engineer II
![[title]](https://pim.heraeus.com/images/HRD/HER_EB_Job-Ad-Header_EU_EN_Working_2375x950px.jpg) |
Job Purpose
Develops and implements engineering solutions to address complaints and product feedback related to manufacturing and non-manufacturing processes, ensuring timely resolution, effective customer communication, regulatory compliance, and continuous improvement of product quality, operational efficiency, and customer satisfaction.
Main Responsibilities:
- Assess processes and products to solve and respond to quality issues.
- Evaluate and implement solutions allowing an optimal Quality Assurance and Preventive Quality.
- Lead the corresponding core teams, to drive initiatives as result of customer complaints.
- Provide technical support for Quality Systems and solve quality issues, often implementing cost-saving measures and high-quality standards.
- Communicate with customers to provide or request information related to their complaints in order to retrieve the necessary details to resolve the issues effectively.
- Provide support for Quality Sustaining Engineering activities when it is required.
- Drive statistical analysis and tools like DOE and Minitab to identify quality issues trends and improve processes.
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.
ReqID: 59042
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