Quality Leader 3rd shift

The Quality Leader works collaboratively with the Production Managers, Quality Manager, Quality Engineers , Process Engineers, Operators, Inventory Techs and members of the Leadership team to perform inspections of all parts and trials. The Quality Leader is the recognized expert on all aesthetics, packaging and label information for inspections on the production floor. The Quality Leader is responsible for all quality documentation in IQMS as well as any physical paperwork.  In addition to normal production, the Quality Leader will assess trials, participate in corrective action meetings, participate in customer interactions, initiate lot traceability and all other aspects of quality that may be required. This role's responsibility is to act in a professional manner and set the example for the team.

Duties include but are not limited to:

1. Inspect molded parts for acceptable quality standards during production, this includes trial parts for existing and new customers.
2. Identify and isolate non-conforming or suspect product including visual and dimensional features. Create MRBs for non-conforming material per documented procedure.
3. Collect a sample or samples representing the typical non-conformity of production that is being placed on MRB and place in bin for the Quality Manager and Quality Engineer.
4. Use gages/mating parts to measure parts and determine acceptability.
5. Ability to use IQMS system to access inspection folders for Operator Instructions. Acceptable and Unacceptable defects, and any additional inspections that may be required.
6. Monitor product at production area and packaging station including verification of count, packaging, and labeling.
7. Train and assist Operators with any visual inspections.
8. Work with Production Managers, Quality  Manager, Quality Engineers and Shift Supervisors to monitor scrap to minimize production waste.
9. Complete daily activities on shift reports when necessary.
10. Have the ability to move efficiently to perform visual inspections, and audit product.
11. Verifies packaging and label information prior to disposition of the product.
12. Practice good communication skills.
13. Share break responsibilities for operators. (Breaks determined by Shift Supervisors)
14. Perform necessary tasks assigned by Quality Manager
15. Daily communication with Inventory Techs: verifying counts for MRBs, production and medical product run needs, reconciliation of labels in medical, and verifying correct labels in production.
16. Understand and apply ISO 13485 to applicable role responsibilities.
17. Understand and apply AS9100 Clauses to applicable role responsibilities
18. Follow requirements of ISO standards to maintain and improve the Quality Management System

Requirements and Qualifications

 Education...     High School Diploma or GED                   

 Essential Knowledge… Basic knowledge of quality principals, ability to work with a computer, a good attitude, a desire to succeed and is not intimidated by confrontation. Professional conduct is required in all situations.  Some supervision skills, intermediate mathematics, reading and writing skills. Organizational skills, ability to prioritize daily tasks, and work as a team member.