Quality Systems Engineer

hace 1 mes


Paraíso, Paraíso, Costa Rica Nextern A tiempo completo
Job Title: Quality Systems Engineer

At Nextern, we are seeking a highly skilled Quality Systems Engineer to join our team. As a key member of our organization, you will be responsible for maintaining and implementing process improvements to our Global Quality System (QMS) procedures.

Key Responsibilities:
  • Lead and facilitate global QMS procedure changes and process improvements to align business processes or changes to industry standards and requirements.
  • Support configuration activities of Agile PLM to support new or improved processes.
  • Utilize project management, Six Sigma, Lean, or other disciplines to improve Quality System processes.
  • Support stakeholders with software validation efforts.
  • Support on-boarding of new employees with Quality System processes and Agile PLM setup.
  • Prepare and analyze Quality System metrics for presentation to stakeholders and top management.
  • Support internal, external, and third-party audits.
Requirements:
  • Bachelor's Degree in Engineering or relevant area, plus 2-5 years of relevant experience in ISO 13485 and FDA GMP.
  • Experience with Quality System process improvement, including project management, document management, data analysis, and presenting to cross-functional teams and leadership.
  • Fully bilingual Spanish-English.
  • Excellent skills in standard computer-based software programs such as Microsoft Office.
  • Excellent learning agility.
  • Ability to effectively build and maintain relationships, communicate, and interact with a variety of personalities.
Preferred Qualifications:
  • Experience with database administration/configuration.
  • Agile PLM, Microsoft Power BI, Epicor (ERP) experience or other similar applications.
  • Project management experience.
  • Training/certification in Lean and Six Sigma.
  • Training/certification in lead auditing ISO 13485 and FDA GMP systems.
What We Offer:

Competitive compensation package.


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