What are the responsibilities and job description for the Quality Engineer position at katecho?
Job Description:
SUMMARY
Responsible for 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 work and communicate with all departments in the area of quality with the goal of Continuous Improvement. This position supports the Engineering and Operations job functions of Quality Assurance to meet organizational objectives.
PRIMARY DUTIES AND RESPONSIBILITIES
- Develops, writes, and executes installation, operation and performance qualification protocols for equipment and systems.
- Devise and implement various methods and procedures for inspection, testing, and evaluating the precision, reliability, and accuracy of products and processes.
- Designs, installs, and evaluates quality process sampling systems, procedures, and statistical techniques.
- Proactively work 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.
- Work with other departments to determine the root cause and determine CAPAs to problems involved with product quality.
- Analyze production and service limitations and standards.
- Formulates or helps formulate quality policies, procedures, and work instructions.
- Works with customers, suppliers, and engineers for First Article Approval and to resolve quality issues as required.
- Assist in quality audits including, but not limited to, FDA, Customer Audits, Supplier Audits, and Internal Audits.
- Serve as Quality technical resource for requirements, risk analysis, process validation, statistical analysis, design transfer, etc.
- Issues and reviews supplier correction actions, to prevent any problem trends from occurring.
- Other duties and functions may be assigned as required.
SECONDARY DUTIES AND RESPONSIBILITIES
- Reviews ECO’s (Engineering Change Orders), requesting or authorizing changes as needed.
- Acts as a leader within the organization demonstrating Katecho’s core values and effectively implementing the Company’s strategy.
- Coordinates documentation of process using ISO format.
AUTHORITY
- Take necessary action required to remedy product quality problems; such as quarantining product or shutting down production, etc.
- Work together with members of the management team to manage the overall direction of Katecho.
- Must complete a Non-Compete Agreement and Patent Agreement.
