Metrology Specialist (1st Shift)
ESSENTIAL FUNCTIONS
Write OGP/Smartscope programs then plan and perform the required setup and 1st article layout of samples for inspection. Collect data, analyze and prepare reports for all measurement and test data on new, transfer, engineering change and sample run parts. Support Engineering personnel with tolerance and GD&T, and capability studies, as well as customer interface to resolve quality issues. The successful candidate will assure that our product conforms to internal and external requirements via Product and Process Validation using our IQ/OQ/PQ system.
Perform calibrations of IM&TE including the reporting and evaluation of internal and external results. Develop and maintain Gage R & R of all equipment and oversee calibration of all gages used within facility utilizing ProGage software.
Maintain close communications with the Manufacturing Department and the Director of Quality to make quality decisions using historical data and experience while assisting in the production of quality products. Initiate, recommend or provide solutions to non-compliances associated with product and/or processes utilizing the CAPA process.
Participate on committees and projects and prepare written reports and documentation for internal and/or external use as required or assigned.
Responsible for following documented procedures established by the Injectronics Quality Management System for ISO 13485 while adhering to all company policies, work environment and safety requirements.
Education & Experience
The qualified candidate is preferred to have an A.S. degree in Engineering and 5 years experience as a Quality Assurance Technician or an equivalent position in the medical device manufacturing industry with experience using basic measuring instruments, CMM, OGP, Blue Print Reading (GD&T datum layouts), calibration tools and test equipment and a working knowledge of Statistical Process Control (SPC) are strongly preferred.Solidworks experience preferred. Proficient in Microsoft Office Suite of products.Estimated Salary: $20 to $28 per hour based on qualifications.
Write OGP/Smartscope programs then plan and perform the required setup and 1st article layout of samples for inspection. Collect data, analyze and prepare reports for all measurement and test data on new, transfer, engineering change and sample run parts. Support Engineering personnel with tolerance and GD&T, and capability studies, as well as customer interface to resolve quality issues. The successful candidate will assure that our product conforms to internal and external requirements via Product and Process Validation using our IQ/OQ/PQ system.
Perform calibrations of IM&TE including the reporting and evaluation of internal and external results. Develop and maintain Gage R & R of all equipment and oversee calibration of all gages used within facility utilizing ProGage software.
Maintain close communications with the Manufacturing Department and the Director of Quality to make quality decisions using historical data and experience while assisting in the production of quality products. Initiate, recommend or provide solutions to non-compliances associated with product and/or processes utilizing the CAPA process.
Participate on committees and projects and prepare written reports and documentation for internal and/or external use as required or assigned.
Responsible for following documented procedures established by the Injectronics Quality Management System for ISO 13485 while adhering to all company policies, work environment and safety requirements.
Education & Experience
The qualified candidate is preferred to have an A.S. degree in Engineering and 5 years experience as a Quality Assurance Technician or an equivalent position in the medical device manufacturing industry with experience using basic measuring instruments, CMM, OGP, Blue Print Reading (GD&T datum layouts), calibration tools and test equipment and a working knowledge of Statistical Process Control (SPC) are strongly preferred.Solidworks experience preferred. Proficient in Microsoft Office Suite of products.Estimated Salary: $20 to $28 per hour based on qualifications.
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