Quality Assurance Technician
hace 4 semanas
Job Summary:
This role is responsible for supporting the Quality Engineer in the validation of the Condor Project.
Key Responsibilities:
- Perform visual inspections, measurements, and functional testing of pipette tips, tubes, and racks.
- Use Agile PLM to read drawings and interpret requirements and tolerances.
- Evaluate results and verify specifications and tolerances as specified on product drawings or Product Quality Requirements.
- Record results in hand-written forms or using templates in Excel.
- Use access database to input final results of tests performed.
- Communicate results and notify the immediate supervisor of any deviations to established standards.
- Use Trackwise System to document Non-Conformances.
- Follow applicable procedures, work instructions, CTQ drawings, and product quality requirements.
- Execute protocols and test plans in the evaluation of plastic components supporting 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.
Requirements:
- Technical career, High school diploma or equivalent required.
- ASQ certification is a plus.
Experience:
- 2+ years' experience related to quality control, preferably in a quality laboratory department with medical devices ISO13435 and FDA 21 CFR part 820 environment.
- Experience measuring parts preferred.
Language Skills:
- 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 on 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.
Company: Thermo Fisher Scientific
Job Type: Temporary
Language: English
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