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.

Experience and Skills:

QUALIFICATIONS

1. Education and/or Experience
   1. Minimum of five years of manufacturing supervision or management experience. Bachelor’s degree in a related field preferred.
   2. Training and/or experience in manufacturing systems with an emphasis on production flow and trouble-shooting.
   3. ASQ & Green Belt certifications completed within 1-year of employment preferred.
   4. Some Lean manufacturing implementation experiences or knowledge preferred.
2. Leadership Ability
   1. Able to lead and influence other employees in the areas of work performance, work quality, dependability, and company loyalty.
   2. Ability to direct and train employees.
   3. Honest and of high integrity
   4. Ability to multi-task and prioritize multiple tasks in order of importance.
   5. Must be able to pass a background check.
   6. 3. Reasoning Ability
   7. a. Able to solve practical problems with a variety of variables in situations where only limited standardization exists.
   8. Able to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
      1. Language/Communication Skills
         1. Able to read, analyze, and interpret general business periodicals, reports, technical procedures, and/or government regulations. Able to read and write English.
         2. Able to write reports, business correspondence, as well as internal procedures and instructions.
         3. Able to effectively present information and respond to questions from customers, managers, and employees.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is frequently required to stand, walk, sit and operate a computer. Specific vision abilities required by this job includes close and distance vision.

WORK ENVIRONMENT

Large open production area with multiple production lines and associated machinery and measuring equipment. May require business attire. May involve working with electrical and measuring equipment.

Benefits

Benefits: PPO/HMO Health, Dental, Vision, FSA, STD/LTD, Life option, 401(k)

PTO: 3 weeks/yr; @10 years - 4 weeks/yr