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Quality Engineer II

Cartago, Costa Rica

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Job ID 59042 Funktionsbereich Qualitätsmanagement Vollzeit/Teilzeit Vollzeit Einstiegslevel Berufserfahrene

Quality Engineer II

[title]
Quality Engineer II
Heraeus Medevio
Location Cartago
Permanent
Full Time

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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