Quality Systems Technician II

hace 7 días

San Rafael, Costa Rica ATL Technology Costa Rica A tiempo completo $40.000 - $80.000 al año

Job Title: Quality Systems Technician II
Department: Quality
Reports to: Quality Engineer / QE Team Lead

Job Summary: The Quality Technician II is responsible for achieving required quality standards and contributing to site performance goals. This role ensures strict adherence to quality work instructions and compliance with ISO, FDA, internal, and external quality system requirements.

Key Responsibilities:

  • Audit processes, test and inspect products.
  • Compile and evaluate statistical data to maintain product quality and reliability.
  • Perform complex engineering testing, root cause analysis, and corrective actions.
  • Approve product, process, and equipment qualifications.
  • Analyze test results and implement process improvements.
  • Maintain laboratory safety and compliance.
  • Perform Incoming, Microbiology, Calibration, and Sterilization tasks.
  • Participate in technical meetings with suppliers and clients.
  • Support Supplier/Customer Quality functions in collaboration with Purchasing and Engineering teams.
  • Co-host customer and regulatory audits.
  • Track and maintain IOUD/Deviation logs.
  • Contribute to CAPA,
  • Complaints, NCMRs, and SCARs.Perform additional tasks as assigned by the manager.
  • Qualifications:
  • High School Diploma required.
  • Associate degree in a technical field or equivalent technical training/certification.
  • 3–5 years of experience in the Medical Devices industry as Quality Systems Technician(required - Quality Systems focused).
  • Working knowledge of 21 CFR 820, ISO 13485, and ISO 14971.
  • Intermediate English level.
  • Strong analytical and problem-solving skills.
  • Proficiency in MS Excel, Word, and PowerPoint.
  • Experience with statistical/data analysis and report writing.
  • Familiarity with quality tools and process improvement methodologies.
  • Ability to interface with cross-functional teams and regulatory bodies.

Language & Mathematical Skills: Ability to read and interpret technical documents and regulations. Strong report writing and presentation skills. Advanced mathematical skills including statistical analysis and sampling theory.
Physical Demands: Occasionally required to stand, walk, and lift up to 25 lbs. Frequently required to sit, use hands, and communicate clearly. Must be able to focus visually and work in moderate noise environments.

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