Job Description:

SUMMARY
Responsible for the designing, installing, and performing risk assessments of quality process systems and statistical techniques internal to Katecho as well as at suppliers. Formulates quality policies, procedures, and work instructions. Works with customers for First Article Approval. Proactively works and communicates with all departments in the area of quality with the goal of Continuous Improvement. This position supports the Engineering job functions of Quality Assurance to meet organizational objectives.

PRIMARY DUTIES AND RESPONSIBILITIES
1. Develops and executes installation, operation and performance qualification protocols for equipment and systems.
2. Designs, installs, and evaluates quality process sampling systems, procedures, and statistical techniques.
3. Proactively works on continuous improvement of the quality system through monitoring of production operations, personnel management, and adherence to and administration of ISO 13485 and FDA, Title 21 Part 820, QSR.
4. Works with other departments to determine to the root cause and solve problems involved with product quality.
5. Analyzes production and service limitations and standards.
6. Formulates or helps formulate quality policies, procedures, and work instructions.
7. Conducts training on quality concepts or tools.
8. Works with customers for First Article Approval and to resolve quality issues as required.
9. Audits Business Management Systems, i.e. ISO 13485 and FDA, Title 21 Part 820, QSR, etc. at Katecho and its supply base.
10. Participates in external quality audits performed by 3rd party auditors.
11. Issues and reviews supplier correction actions to prevent any problem trends from occurring.
12. Regular and reliable attendance is an essential function of this job. Punctuality and regular attendance are crucial for efficient plant operations, safety, and morale.
13. Other duties and responsibilities may be assigned as required.

SECONDARY DUTIES AND RESPONSIBLITIES
1. Reviews ECO’s (Engineering Change Orders), requesting or authorizing changes as needed.
2. Acts as a leader within the organization demonstrating Katecho’s core values and effectively implementing the Company’s strategy.
3. Coordinates documentation of process using ISO format.

AUTHORITY

1. Takes necessary action required to remedy product quality problems such as quarantining product or shutting down production, etc.
2. Determines and request necessary resources (personnel, equipment, supplies, etc.) to effectively run the Quality department.
3. Works together with members of the management team to manage the overall direction of Katecho.

Experience and Skills:

QUALIFICATIONS
1. Education and/or Experience
• Bachelor’s degree in engineering, manufacturing, or business preferred.
• 3-5 years’ experience working withing quality engineering systems.
• Experience working with business management systems particularly ISO 13485 preferred, and FDA Title 21 Part 820, QSR.
• Ability to attain ASQ Quality Engineer Certified within one (1) year upon demand.
• Experience in SPC and Statistical Analysis.
• Computer skills in MS-Office and Statistical Analysis Software.
• Self-motivated analytical data driven decision maker with strong leadership skills.
• Strong commitment to quality and customer service.
• Demonstrates problem-solving skills required. lead and influence others by example in the areas of attitude, work quality, work ethic, dependability, and company loyalty.
2. Leadership Ability
• Able to lead and influence other employees in the areas of work performance, work quality, dependability, and company loyalty.
3. 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.
4. 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.
• Strong written and verbal communication skills.
• Ability to effectively present information and respond to questions from customers, manager, and employees.
• Must complete a Non-Compete Agreement and Patent Agreement.

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 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. The employee must be able to communicate with speech and hearing. Specific vision abilities required by this job include vision, distance vision, and color determination.

WORK ENVIRONMENT
Office environment with business casual dress. May require business attire. Some travel may be required.

Benefits

Benefits Include:

• Medical (PPO or HMO)
• Dental and Vision coverage
• Flexible Spending Account (FSA)
• Short-Term Disability (STD)
• Voluntary Long-Term Disability (VLTD)
• Basic Life Insurance
• Voluntary Term Life (VTL) Insurance

401(k) Retirement Plan:
We offer a 401(k) with a company match of 50% on the first 6% of employee contributions. Employees are fully vested after 3 years of service.