About Company:
One Euro Medical Company
Responsibitilies:
1. Establish and maintainquality control standards, processes, and procedures to ensure manufacture quality control and assurance activities are executed in an effective way;
2. Establish key manufacture quality metrics and develop data collection, analysis, and reporting systems, which promote timely monitoring, communication and corrective/preventive action;
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3. Report nonconformities in the quality control to Invisalign management team;
4. Represent quality function on new Product Development and/or transfer projects;
5. Work with Production, Engineering, MNT and other functions on process improvement activities, including process capability studies and gauge reproducibility & repeatability (R&R) studies on selected process parameters and inspection devices;
6. Represent QA and work with Production, Engineering and MNT on equipment qualifications and process validations. Review and approve all non-SW related IQ/OQ/PQ;
Requirements:
1. Bachelor's degree or above in engineering or science related.
2. 8+ years working experience at a manufacturing firm quality role, at least 5 years quality management experience as a quality manager/quality senior engineer role.
3. Familiar with NPI and design transfer process, familiar with validation (IQ,OQ,PQ) process.
4. Work experience in an American/European medical device company is desired.
