Lead Qc Technician - Tijuana, México - Thermo Fisher Scientific

Thermo Fisher Scientific

Empresa verificada

Tijuana, México

hace 3 días

Publicado por:

Rodrigo Fernández

Reclutador de talento para beBee

Descripción

Summary:

You will visually inspect, measure and perform functional testing on pipette tips, tubes and racks using a variety of equipment.

Support to the Quality Supervisor to coordinate quality inspection activities from quality inspectors or Lab technicians.

Responsibilities:

Conduct visual inspections, measurements and functional testing for pipette tips, tubes and racks (e.g. use calipers, comparator, CMM, gages, centrifuge, manual pipettes).
Evaluate results and verify specifications and tolerances as specified on product drawing or Product Quality Requirements. Records results in handwritten forms or using templates in Excel.
Use Agile PLM to read drawings, able to 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. Use Trackwise System to document Non-Conformances.
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 create or refine measurement routines for CMM and VMM equipment.
Execute protocols and test plans in the evaluation of plastic components supporting to Quality Engineers.
Manage release of manufacturing lots
Follows 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 need it.
Support in the calibration process
Support during internal and external audits.
Other duties may be assigned as required.

Education:

Bachelor's degree, technical career or equivalent required.
ASQ certification is desired.

Experience:

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.

Languages:

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 MS Excel, 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 problemsolving skills (root cause analysis, CAPA)
Attention to detail and ability to identify and remediate compliance issues.
Highly effective verbal and written skills