Job Description:

SUMMARY

Work with the head of Quality to proactively lead the quality system efforts at Katecho through monitoring of production operations, personnel management, and adherence to and administration of the ISO 13485 and FDA Title 21 Part 820, QSR. Effectively lead and supervise the Quality Department personnel working in the manufacturing areas at Katecho.

PRIMARY DUTIES AND RESPONSIBILITIES

1. Lead a team of people by example in the areas of work performance, work quality, dependability, and communication.
2. Proactively work on continuous improvement of the quality system through monitoring of production operations, personnel management, and adherence to and administration of the ISO 13485 and FDA, Title 21 Part 820, QSR.
   1. Work with other departments to determine the root cause and solve problems involved with product quality.
3. Supervise the Quality Department personnel reporting to this position in the following areas (working with Human Resources):
   1. Staffing
   2. Development and training
   3. Rewarding, reviewing, and disciplining
4. Proactively work and communicate with all departments at Katecho in the area of quality with the goal of continuous improvement.
5. Supervise all Quality Department Inspection Staff, Receiving Staff, and Test Lab Staff personnel on production floor area. (Heat seal, Sampling and Receiving). Ensure efficient utilization of personnel.
6. Ensure product is inspected in a timely and accurate manner in accordance with Katecho quality standards, ISO 13485 and FDA, Title 21 Part 820, QSR.
7. Expedite workflow.
8. Makes decisions regarding inspection and inspection plans.
9. Other duties and functions may be added to the above job description as required by leadership.

AUTHORITY

1. May shut down manufacturing processes or quarantine product for reasons pertaining to quality.
2. Supervise and discipline employees. Conduct employee interactions according to company policy and working with Human Resources.
3. Delegate and assign work to Quality personnel reporting to this position.
4. Must complete a Non-Compete Agreement and Patent Agreement.