Quality Engineer II | M-F | Pay Based on Experience

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.