Lead Qc Technician

hace 4 semanas

Tijuana, México Thermo Fisher Scientific A tiempo completo

**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 hand-written 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**:

- 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 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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