Sr QA Technician - Tijuana, México - Thermo Fisher Scientific
Descripción
Summary:
You will visually inspect, measure and perform functional testing on pipette tips, tubes and racks using a variety of equipment.
Responsibilities:
- Conduct visual inspections, measurements and functional testing for pipette tips, tubes and racks (e.g. use calipers, comparator, CMM, gages, centrifuge, manual pipettes).
- Use Agile PLM to read drawings, able to interpret drawing requirements and tolerances
- 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 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.
- Maintain lab equipment, establish traceability of laboratory standards.
- Follows applicable procedures, work instructions, CTQ drawings, product quality requirements.
- Write lab procedures and associated training materials using Agile System
- Execute protocols and test plans in the evaluation of plastic components supporting to Quality Engineers.
- Support during internal and external audits.
- Participate actively in PPI events as per the organization's requirements.
- Other duties may be assigned as required.
Education:
- Technical career, High school diploma or equivalent required.
- ASQ certification is a plus.
Experience:
- 2+ 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: 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 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
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