Designation: Quality Engineer
- Identify and review Part Qualification documents such as First Article Inspection, Gage R&R, Process Failure Mode Effect Analysis, capability study, control plan, process validation etc.
- Develop requirements for quality inspection of incoming material from supplier.
- Conduct supplier audits and manage audit corrections.
- Facilitate the completion of Supplier Corrective Action Request and Vendor Quality Notices from supplier. Perform activities to build Design History File and Device Master Record documents.
- Perform gap analysis to update procedures and documentation to meet the new European Medical Device Regulation.
- Conduct DFx reviews with external suppliers.
- Perform manufacturing line 5S reviews.
- Participate in Root cause investigations. Identify and Mitigate Quality Risk inside plant.
- Participate in engineering design reviews and provide inputs.
- Review and disposition product design and manufacturing process changes orders.
- Perform manufacturing area audit to review compliance to FDA 21 CFR Part 820 regulation.
- And any additional duties as deemed necessary for the project.