Quality Engineer Job

A Quality Engineer is needed to perform the following duties:

· · Led risk management planning, conducting DFMEA, PFMEA, and Hazard Analysis for new and existing medical devices.

· Ensured compliance with ISO 13485, ISO 14971, US FDA 21 CFR 820, and EU MDR in design and manufacturing activities.

· Analyzed process capability and variability to optimize production and validation protocols (IQ, OQ, PQ).

· Developed technical files and conducted gap assessments for EU MDR compliance and Medical Device Reporting (MDR).

· Managed supplier qualification projects, verifying pFMEA, Material Supplier Risk Summary (MSRS), and component qualification plans.

· Developed and standardized work instructions for 2700+ SKUs, documenting best practices for manual finishing operations (deburring, polishing, welding, blasting, inspection, and assembly).

· Conducted time studies, optimizing process flow and reducing cycle times in manual finishing operations.

· Designed and implemented 3D-printed assembly fixtures using SolidWorks, leading to a drastic reduction in assembly times and higher-quality assembled products.

· Provided real-time manufacturing support, troubleshooting equipment issues and coordinating NCMRs to prevent backorders.

· Performed statistical data analysis, including normality assessment, process capability analysis, and gage R&R studies, to drive process improvements.

· Ensured compliance with GDP (Good Documentation Practices) and contributed to the implementation of 1Factory.

Bachelor's Degree in Mechanical Engineering or Manufacturing Engineering

Health/Dental Benefits, Paid Holidays, Vacations, and Sick Leave