Norwood Medical
Quality Inspector- New Product Development
Norwood Medical, Dayton, Ohio, United States, 45444
Description
The Quality Lab Inspector in New Product Development plays a critical role in ensuring the quality and reliability of new medical components throughout their development lifecycle. This position is responsible for performing meticulous inspections, tests, and analyses of prototypes, pilot runs, and pre-production samples to verify adherence to design specifications, regulatory requirements (e.g., FDA, ISO 13485), and internal quality standards. The inspector will work closely with R&D, engineering, and manufacturing teams to identify and document non-conformances, provide crucial data for design validation, and contribute to the successful launch of safe and effective medical devices. Responsibilities include: Execute a complex inspection plan, such as a Manufacturing Inspection Plan (MIP) or inspection data sheet, to verify part quality with visual checks and use of inspection equipment such as calipers, micrometers, gauges, indicator, comparator, microscope, Fowler, Keyence, Equator, CMM, Smartscope , etc. Verify product conformance by performing set-up verification (Green Tag), Planned Process Verification (PPV), Final Inspections, and First Article Inspections Ensure proper function of inspection equipment by mastering a gauge or gauge system and set mastering of part specific gauges Troubleshoot inspection failures by utilizing secondary measurement methods such as manual checks with a Smartscope, picking CMM datum points, etc. and find quality defects that were not previously defined Perform programming of advanced inspection systems such CMM, Smartscope, Fowler, etc. Troubleshoot and resolve quality functionality issues with the use of established standards and by recommending inspection processes and creating best quality practices Complete capability studies and analyze data for process capability input (CPK)
Requirements
Able to work independently while following established methods and procedures and suggest other actions to perform operations required for successful quality inspection
Competency in understanding and reading a vernier scale
Use of Microsoft Excel and Microsoft Outlook and Minitab
Basic computer skills
Competency in general blueprint reading
Understanding of advanced geometric dimensioning and tolerancing (GD&T)
Understanding of repeatability and reproducibility (gauge R & R)
Knowledge of Open Plate Layout and process capability input (CPK)
Ability to lift up to 35 pounds
Ability to stand, sit, or move about the facility
The Quality Lab Inspector in New Product Development plays a critical role in ensuring the quality and reliability of new medical components throughout their development lifecycle. This position is responsible for performing meticulous inspections, tests, and analyses of prototypes, pilot runs, and pre-production samples to verify adherence to design specifications, regulatory requirements (e.g., FDA, ISO 13485), and internal quality standards. The inspector will work closely with R&D, engineering, and manufacturing teams to identify and document non-conformances, provide crucial data for design validation, and contribute to the successful launch of safe and effective medical devices. Responsibilities include: Execute a complex inspection plan, such as a Manufacturing Inspection Plan (MIP) or inspection data sheet, to verify part quality with visual checks and use of inspection equipment such as calipers, micrometers, gauges, indicator, comparator, microscope, Fowler, Keyence, Equator, CMM, Smartscope , etc. Verify product conformance by performing set-up verification (Green Tag), Planned Process Verification (PPV), Final Inspections, and First Article Inspections Ensure proper function of inspection equipment by mastering a gauge or gauge system and set mastering of part specific gauges Troubleshoot inspection failures by utilizing secondary measurement methods such as manual checks with a Smartscope, picking CMM datum points, etc. and find quality defects that were not previously defined Perform programming of advanced inspection systems such CMM, Smartscope, Fowler, etc. Troubleshoot and resolve quality functionality issues with the use of established standards and by recommending inspection processes and creating best quality practices Complete capability studies and analyze data for process capability input (CPK)
Requirements
Able to work independently while following established methods and procedures and suggest other actions to perform operations required for successful quality inspection
Competency in understanding and reading a vernier scale
Use of Microsoft Excel and Microsoft Outlook and Minitab
Basic computer skills
Competency in general blueprint reading
Understanding of advanced geometric dimensioning and tolerancing (GD&T)
Understanding of repeatability and reproducibility (gauge R & R)
Knowledge of Open Plate Layout and process capability input (CPK)
Ability to lift up to 35 pounds
Ability to stand, sit, or move about the facility