Quality Control Specialist

hace 4 semanas


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

Job Summary

Thermo Fisher Scientific is seeking a highly skilled Quality Control Specialist to join our team. As a Quality Control Specialist, you will be responsible for visually inspecting, measuring, and performing functional testing on pipette tips, tubes, and racks using a variety of equipment.

Key Responsibilities

  • Conduct visual inspections, measurements, and functional testing for pipette tips, tubes, and racks.
  • Evaluate results and verify specifications and tolerances as specified on product drawings or product quality requirements.
  • Use Agile PLM to read drawings, interpret drawing requirements, and tolerances.
  • Use access database to input final results of tests performed.
  • Communicate results to the immediate supervisor of any deviation to the established standards.
  • Collaborate with product design and metrology engineers to develop equipment and fixturing for NPD projects.
  • Maintain lab equipment, establish traceability of laboratory standards.
  • Write lab procedures and associated training materials using Agile System.
  • Collaborate on creating or refining measurement routines for CMM and VMM equipment.
  • Execute protocols and test plans in the evaluation of plastic components supporting Quality Engineers.
  • Manage release of manufacturing lots.
  • Follow applicable procedures, work instructions, CTQ drawings, product quality requirements.
  • Participate actively in PPI events as per the organization's requirements.
  • Maintain DHR temporary archive safe and protected.
  • Train inspectors on formats, procedures, routine equipment, etc., as needed.
  • Support in the calibration process.
  • Support during internal and external audits.

Requirements

  • Technical career or equivalent required.
  • ASQ certification is desired.
  • 5 years' experience related to quality control, preferably in the quality laboratory department with medical devices ISO13435 and FDA 21 CFR part 820 environment.
  • Specific experience with various measurement equipment, such as CMM, vision measurement systems, and mechanical gauging/fixturing.
  • English spoken: Intermediate.
  • English writing: Intermediate.

Skills

  • Ability to interpret drawing requirements and tolerances.
  • Knowledge of working in a lab environment.
  • Ability to manage, lead, and motivate a QA Team.
  • 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, and use of software systems (Agile, Trackwise, Macola).
  • Intermediate math skills.
  • This position requires flexibility with work hours to meet customer demands and business priorities and objectives.
  • 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.


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