Quality Control Specialist
hace 4 semanas
Job Summary
Thermo Fisher Scientific is seeking a highly skilled Quality Control Specialist to join our team. As a Quality Control Specialist, you will be responsible for visually inspecting, measuring, and performing functional testing on pipette tips, tubes, and racks using a variety of equipment.
Key Responsibilities
- Conduct visual inspections, measurements, and functional testing for pipette tips, tubes, and racks.
- Evaluate results and verify specifications and tolerances as specified on product drawings or product quality requirements.
- Use Agile PLM to read drawings, 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.
- 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 creating or refining measurement routines for CMM and VMM equipment.
- Execute protocols and test plans in the evaluation of plastic components supporting Quality Engineers.
- Manage release of manufacturing lots.
- Follow 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 needed.
- Support in the calibration process.
- Support during internal and external audits.
Requirements
- Technical career or equivalent required.
- ASQ certification is desired.
- 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.
- 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 on MS Excel, and 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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