Quality Assurance Specialist
Vor 3 Tagen
We are seeking a Quality Assurance Specialist to join our team. This is an exciting opportunity for a motivated and detail-oriented individual to work in a dynamic environment.
The Quality Assurance Specialist will be responsible for ensuring the quality of our products by supporting the team dedicated to New Product introduction, participating in Design transfer meetings, and providing input to DFMEA. They will also ensure CTQ cascade from Design input up to the inspection plan, develop appropriate measurement systems (Gages) for ongoing product inspection, and plan and execute Test Method validation (TMV).
The ideal candidate will have a minimum Bachelor Degree in a technical field such as Biomedical/Mechanical/Automation engineering, with at least 3 years of experience in a manufacturing environment, preferably in the Medical Device or pharmaceutical industry. Knowledge of standards such as ISO13485, CFR 21 part 820, MDR, Six Sigma techniques, and inferential statistical techniques is required.
The successful candidate will possess strong organizational skills, be independent, positive, persistent, proactive, and have strong communication skills. They will also be able to translate complex situations into simple solutions, plan, schedule, and perform moderately complex engineering projects to evaluate, select, and adapt or modify standard manufacturing techniques, procedures, and criteria to increase the efficiency of plant operations.
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