Job Description:

Job Title

Director of Quality

Position/Level

Director

FLSA Status

Salary Exempt

Department

Quality

Reports to

VP of Quality

Direct Reports

Quality Systems Manager, Quality Control Manager

SUMMARY

Directs all quality functions at Katecho to assure that all products manufactured by the organization meet customer specifications and regulatory requirements, and achieve superior quality and reliability levels. Directs the Quality Department to effectively and efficiently maintain and improve the level of quality at Katecho.

PRIMARY DUTIES AND RESPONSIBILITIES

1. Is a key contributor to the overall quality direction of the company. Communicates and works together with other management at Katecho to maintain and improve the direction of the company.
2. Develop and implement the quality assurance and quality control programs at Katecho to ensure conformity of processes to established quality standards.

a. Assure that the internal quality system meets the requirements of ISO 13485, FDA Title 21 CFR Parts 11, 211, 820 etc., Canada MDD CANCMS, and Japanese Ministry of Health PDMR;

1. Prepare for and represent the company as the designated management representative during all ISO 13485, FDA Title 21 CFR Parts 11, 211, 820 etc., Canada MDD CANCMS, and Japanese Ministry of Health PDMR and customer audits.
2. Report to management on the performance of the QMS and the avenues for improvement.
3. Ensure the promotion of awareness of regulatory and customer requirements throughout the organization.
4. Proactively work and communicate with all departments at Katecho in the area of quality with the goal of continuous improvement.
5. Communicate with customers, vendors, quality representatives, and company personnel to discuss and resolve quality problems as required.
   1. Assures customer surveys are completed
   2. Responsible for Quality component of Supplier Scorecard
   3. Oversee the management of the customer complaint process.
      1. Ensure complaints are processed and investigated in a timely, accurate and efficient manner.
      2. Work with the customers to resolve the issues surrounding the complaints, and institute corrective and preventative actions resulting from the investigation of the complaint.
      3. Provide technical guidance and assist in the R & D functions of the company.
      4. Oversee the management of the Quality Department(s) personnel in the following areas (working with Human Resources):
         1. Staffing
         2. Development and training

c. Rewarding, reviewing, and disciplining

1. Communicate and work together with other management and departments at Katecho to maintain and improve the overall direction of the company.
2. Implement an effective internal auditing program.
3. Other duties and functions may be assigned as required.

AUTHORITY

1. Take necessary action required to remedy product quality problems; such as quarantining product or shutting down production, etc.
2. Initiate a product recall if required.
3. Determine and request necessary resources (personnel, equipment, supplies, etc.) to effectively run the Quality Department.
4. Hire, reward, review, discipline, and terminate personnel in the Quality Department according to company policy and applicable legal requirements.
5. Provides direction on the quality assurance and quality control functions of Katecho. This includes the organization and scheduling of the department.
6. Directs the quality assurance and quality control functions of Katecho. This includes organization and scheduling of the department.
7. Works together with other members of the management team to manage the overall direction of Katecho.
8. Must complete a Non-Compete Agreement and Patent Agreement.

Experience and Skills:

QUALIFICATIONS

Education and/or Experience

• Bachelor’s degree in related area preferred.
• Statistical analysis, precision measurement, and process capability studies are an intricate part of the quality assurance program; therefore, formal education in courses related to these areas such as mathematics, statistics, and industrial practices are strongly desired for this position.
• Some quality assurance practices as they apply to individual unique products can be learned during on-the-job training, but overall capability in this discipline must be previously demonstrated.
• Minimum of five years of experience in a quality related supervisory or management role.

Leadership Ability

• Able to lead and influence other employees in the areas of attitude, work ethic, dependability, and company loyalty.

Reasoning Ability

• Able to solve practical problems with a variety of variables in situations where only limited standardization exists.
• Able to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Language/Communication Skills

• Able to read, analyze, and interpret general business periodicals, reports, technical procedures, and/or government regulations.
• Able to write reports, business correspondence, as well as internal procedures and instructions.
• 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 include close and distance vision.

The customer interaction portion of this position requires the employee to communicate with speech and hearing. The employee must be able to travel by air as well as ground transportation.

WORK ENVIRONMENT

Office environment with business casual dress. May require business attire.

Benefits

PPO/HMO Health, Dental, Vision, FSA, Life options, LTD/STD options, 401(k), 4 wks PTO/yr