**Summary**:
Temporary position to support to Quality Engineer to carry out validations from Condor Project.
**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 hand-written forms or using templates in Excel.
- Use access database to input final results of tests performed.
- Communicate results and notifies to the immediate supervisor of any deviation to the established standards. Use Trackwise System to document Non-Conformances.
- Follows applicable procedures, work instructions, CTQ drawings, product quality requirements.
- 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 Write lab procedures and associated training materials using Agile System
- 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.
- Experience measuring parts preferred.
**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 problem-solving skills (root cause analysis, CAPA)
- Attention to detail and ability to identify and remediate compliance issues.
- Highly effective verbal and written skills