Job Description:

Responsible for the formulation of procedures and work instructions. Proactively work and communicate with all departments in the area of quality with the goal of Continuous Improvement. This position supports all divisions and departments throughout the company in order to meet organizational objectives.

PRIMARY DUTIES AND RESPONSIBILITIES

1. Validates document control systems, both current and obsoleted systems, (i.e. IQMS, DOT) and internally created systems (i.e. Lot Number Database).
2. Proactively works on continuous improvement, as part of the quality process, though monitoring of production operations, personnel management, adherence to and administration of ISO 13485, FDA Title 21 CFR Part 820, and the QSR.
3. Works with other departments to determine the root cause and solve problems involved with product quality.
4. Formulates or helps formulate quality policies, procedures, and work instructions.
5. Conducts training on quality concepts and/or tools.
6. Audits Business Management Systems, i.e. ISO 13485, FDA Title 21 CFR Part 820, QSR, etc. at Katecho and its supply base.
7. Participate/ Lead internal and external quality audits performed by 3rd party auditors, customers and regulatory bodies.
8. Help manage Katecho’s document control system to ensure procedures are maintained based on FDA/ISO standards and regulations.

SECONDARY DUTIES AND RESPONSIBILITIES

1. Reviews ECOs (Engineering Change Orders), authorizing changes as needed.
2. Batch Record reviews.
3. Conducts internal investigations in Manufacturing and the Lab.
4. Assists others in work order packet creation/closure
5. Provides customer support for documentation needs for medical device regulatory filings (PMA, 510(k), etc.)
6. Other duties and functions may be assigned as required.

AUTHORITY

1. Suggests and/or request the necessary resources (personnel, equipment, supplies, etc.) to ensure the Quality Department runs efficiently.
2. Works together with members of the management team to manage the overall direction of Katecho.
3. Must complete a Non-Compete Agreement and Patent Agreement.

Experience and Skills:

QUALIFICATIONS

1. Bachelor’s degree in Engineering or Science related field; or equivalent experience.
2. 3-5 years’ experience working within Quality Systems/ Engineering.
3. Experience working with business management systems, particularly with ISO 13485 preferred, and FDA Title 21 CFR Part 820, QSR.
4. Self-Motivated analytical data driven decision maker with strong leadership skills.
5. Strong commitment to quality and customer service.
6. Demonstrated problem solving skills required.
7. Ability to lead and influence others by example in the areas of attitude, work quality, work ethic, dependability, and company loyalty.
8. Able to solve practical problems with a variety of variables in situations where only limited standardization exists.
9. Able to read, analyze, and interpret government regulations, reports, and general business reports.
10. Able to write business correspondence, reports, internal procedures, and instructions.
11. Strong written and verbal communication skills.
12. Able to effectively present information and respond to questions from customers, managers, and employees.
13. Must be able to pass a background check.

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.

WORK ENVIRONMENT

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

Benefits

Full Benefits package including medical, dental, vision, short and long term disability, life insurance, Flex plan, and 401k. 

PTO upon hire