What are the responsibilities and job description for the Quality Engineer III | 5+ Years Experience | Monday–Friday | Pay Based on Experience position at katecho?
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.