Quality Engineer

POSITION PURPOSE:

The Quality Engineer is responsible for supporting the effectiveness of the Quality Management System (QMS) and to ensure compliance of QMS activities to ISO13485:2016.  Partner with management team to ensure adherence to the QMS.  Provide consistent product and process support for shop floor manufacturing to ensure maximized uptime and high product quality is achieved.

ESSENTIAL FUNCTIONS - The following list of essential job functions is not exhaustive and may be supplemented as necessary based on business needs.

1. Supports the maintenance of the QMS ensuring its continuing suitability, adequacy and effectiveness
2. Shop floor support for troubleshooting, root cause analysis, support production uptime with engineering
   1. Red Cart Process and Gemba Walk
3. Corrective and Preventive Action System (CAPA) ownership
4. Support the Equipment Qualification and Validation Process (including IQ, OQ and PQ, etc)
   1. Works with Engineering to draft and execute protocols
5. Nonconforming Material System (NCMR) ownership and leads the MRB process where applicable
6. Performs First Article Inspections (FAI) with QC Personnel
7. Where applicable, creates and executes Measurement System Analysis (Gage R&R)
8. Support day to day operations to drive Key Process Indicator (KPI) improvements and business objectives
9. Supports the Approved Supplier List (ASL) Evaluations, Reporting and Feedback
10. Creates and edits Standard Operating Procedures, Work Instructions and Forms 
11. Provides input to FMEAs / Risk Management
12. Performs Product Quality Inspections as needed
13. Performs Measuring and Monitoring Equipment Calibration as needed
14. Performs Training as needed
15. Perform other relevant duties as assigned by supervisor