WesternScott Fetzer
Quality Engineer
Job Location
Job Description
Job Summary: |
The Quality Engineer supports product and process design controls through the development and execution of quality plans and continuous improvement. They must be able to identify, implement, and monitor improvements that serve to reduce fallout, rework, and scrap. To develop and maintain process validation plans and protocols. To identify, respond to, and investigate quality issues that impact the ability to meet customer requirements and ensure product safety and efficacy. Drive process improvement change based on quality metrics, tact times, and identified root causes. Participate in preparation and support third party and regulatory audits. Drive product nonconformity disposition. |
Essential Duties, Responsibilities and Authorities Include the following. Other duties may be assigned. |
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Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. | |
Knowledge of: |
Validation concepts (process / equipment / software), root cause analysis, medical device regulations, ISO9001, ISO13485, 21 CFR 820, metrology, SPC, gauge R&R, engineering prints/drawings, statistical sampling. Familiarity with machining and related processes – turning, drilling, milling, deburring, cleaning, and plating
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Skills/Ability to: | Develop and lead validation efforts for processes, equipment, and software. Identify, react to and mitigate risk associated with the discovery of nonconformance events. Develop and implement changes to support continuous improvement. |
Acceptable Experience or Training: | |
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Certificates, Licenses, Registrations: | |
A valid driver’s license is needed to enable occasional travel between Western Enterprises facilities. | |
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 with disabilities to perform the essential functions. | |
The typical workday consists of periods of sitting, standing, desk work, hands on inspection of product, and those activities typical of a manufacturing or quality engineer. The work schedule is Monday to Friday, 8:00 AM to 5:00 PM, with occasional overtime required, dependent upon workload and organizational commitments. | |
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. | |
The work environment consists of both a typical administrative office area, and a manufacturing shop floor, with some specific areas that require eye and hearing protection. |
PI1b8472da9813-30210-34482679
Location: Westlake, Ohio, US
Posted Date: 9/2/2024
Contact Information
Contact | Human Resources WesternScott Fetzer |
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