Electrophysiology Quality Assurance Specialist

hace 2 días


Alajuela, Alajuela, Costa Rica Abbott Laboratories A tiempo completo

About Abbott Laboratories

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As a global healthcare leader, we're advancing medical technologies to improve people's health. Our focus is on creating breakthrough science that anticipates changes in medical science and technology.

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Working at Abbott Laboratories

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We offer opportunities for growth, learning, and development. Our work culture values diversity, inclusivity, and employee well-being. Join us and be part of a team that makes a difference in the lives of others.

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The Opportunity

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This role is based in our Costa Rica location, working within the Electrophysiology Division. We're dedicated to developing medical technologies that treat heart disease, enabling people to restore their health and live life to the fullest.

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Job Description

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As a Quality Engineer II, you'll collaborate with Manufacturing and Engineering teams to ensure compliance with quality system requirements. You'll own process/product validation activities, work closely with R&D/Design Quality, and conduct technical investigations.

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Key Responsibilities:

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  • Verify adherence to established quality systems and standards.">
  • Complete risk management and risk analysis, including FMEA.">
  • Work with R&D/Design Quality to revise design verification and validation plans.">
  • Conduct technical and statistical investigations concerning optimization and compliance to specification.">
  • Own measuring process capability, process controls, and process validation efforts.">
  • Collaborate with Microbiology to ensure environmental monitoring and microbiology requirements are considered in product and process development activities.">
  • Support Major Quality System investigations, such as CAPAs and HHEs.">
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Requirements:

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To be successful in this role, you should have:

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  • A Bachelor's Degree in STEM (Science, Technology, Engineering, or Math) field.">
  • 1-2 years' experience in Quality or Engineering positions.">
  • Knowledge of statistical/data analysis and report writing experience.">
  • Experience working in FDA, GMP, and ISO 13485 regulated environments.">
  • Skills in process improvement tools, such as Root Cause Analysis and Six Sigma.">
  • Familiarity with control of nonconforming material and corrective actions.">
  • Intermediate English proficiency for communication and documentation.">
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Benefits:

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As an employee of Abbott Laboratories, you'll enjoy diverse opportunities for growth, professional development, and employee benefits. Follow your career aspirations with us

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About Abbott Laboratories

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Abbott Laboratories is an Equal Opportunity Employer committed to employee diversity.



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