Quality Systems Engineer

hace 3 semanas


Paraíso, Paraíso, Costa Rica Nextern A tiempo completo

The Global Quality System Process Specialist will be responsible for maintaining and implementing process improvements to Nextern's Quality System procedures, including software configuration and supporting internal audits. This position requires experience with Agile PLM, data analysis, and presentation to cross-functional teams and leadership.

Duties and Responsibilities:

  • Lead and facilitate global Quality System procedure changes and process improvements to align business processes with industry standards and requirements.
  • Support configuration activities of Agile PLM to support new or improved processes.
  • Utilize Project Management, Six Sigma, and Lean disciplines to improve Quality System processes.
  • Support stakeholders with software validation efforts and prepare Quality System metrics for presentation.
  • Support internal and external audits, and perform other related duties assigned by management.

Requirements:

  • Bachelor's Degree in Engineering or relevant field, plus 2-5 years of experience in ISO 13485 and FDA GMP.
  • Fully bilingual Spanish-English, with excellent skills in standard computer-based software programs.
  • Excellent learning agility, self-motivation, and ability to prioritize multiple tasks under pressure.
  • Ability to effectively build and maintain relationships with a variety of personalities.

Preferred Qualifications:

  • Experience with database administration/configuration and Agile PLM.
  • Training/certification in Lean and Six Sigma, and lead auditing ISO 13485 and FDA GMP systems.

Benefits:

Competitive compensation package.



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