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Quality Control Technician

hace 2 meses

Tijuana, Baja California, México Thermo Fisher Scientific A tiempo completo

**Job Summary:**

We are seeking a highly skilled Quality Control Technician to support our Quality Engineer in carrying out validations for the Condor Project. As a key member of our team, you will be responsible for conducting visual inspections, measurements, and functional testing of pipette tips, tubes, and racks.

**Key Responsibilities:**

  • Conduct visual inspections, measurements, and functional testing of pipette tips, tubes, and racks using calipers, comparators, CMM, gages, centrifuge, and manual pipettes.
  • Use Agile PLM to read drawings and interpret drawing requirements and tolerances.
  • Evaluate results and verify specifications and tolerances as specified on product drawings or Product Quality Requirements.
  • Record results in hand-written forms or using templates in Excel.
  • Use an access database to input final results of tests performed.
  • Communicate results and notify the immediate supervisor of any deviation to established standards.
  • Use Trackwise System to document Non-Conformances.
  • Follow applicable procedures, work instructions, CTQ drawings, and product quality requirements.
  • Execute protocols and test plans in the evaluation of plastic components supporting Quality Engineers.
  • Support during internal and external audits.
  • Participate actively in PPI events as per the organization's requirements.

**Requirements:**

  • Technical career, High school diploma or equivalent required.
  • ASQ certification is a plus.
  • 2+ years' experience related to quality control, preferably in a quality laboratory department with medical devices ISO13435 and FDA 21 CFR part 820 environment.
  • Experience measuring parts preferred.
  • English spoken: English basic that can have a conversation.
  • English writing: intermediate.

**Skills:**

  • Ability to interpret drawing requirements and tolerances.
  • Knowledge of working in a lab environment.
  • Ability to work both independently and as a team member.
  • Ability to write reports/protocols.
  • Ability to function in a multifaceted environment and balance multiple priorities simultaneously.
  • Strong computer skills including Microsoft Office with a focus on MS Excel, use of software systems (Agile, Trackwise, Macola).
  • Intermediate math skills.
  • Innovative thinking and problem-solving skills (root cause analysis, CAPA).
  • Attention to detail and ability to identify and remediate compliance issues.
  • Highly effective verbal and written skills.