Position Summary
The Quality Engineer III will be responsible for providing quality assurance support for manufacturing. This position is responsible for the definition, implementation, and improvement of quality related practices and will provide technical guidance and measurement methodologies support.
Responsibilities
Quality engineering support for manufacturing and project management
Develop inspection requirements; facilitate PFMEAs; resolve discrepant material issues and create and maintain quality document such as control plans and inspection plans
Analyze data and identify improvement opportunities
Act as the quality interface for a production team in responding to customer complaints using failure analysis, development of corrective and preventative actions and trend analysis
Conduct audits, including closing out audit findings, create audit finding reports and determine proper corrective and preventative actions
Coach and mentor Quality Engineer levels, I and II
Subject matter expert in one or more areas of the ASQ (American Society for Quality) QE BOK (Body of Knowledge)
Lead and participate in large company projects providing quality recommendations
Support Quality Inspectors to ensure that inspection plans comply with the relevant requirements of customer's product requirements
Support validation activity of processes, equipment, and metrology
Create protocols and analyze data
Support the Quality Inspectors to ensure that inspection plans comply with the relevant requirements of customer's product requirements
Ensure business systems are implemented, maintained, and functioning properly
Support and comply with the company Quality System, ISO, and medical device requirements
Read, understand, and follow work instructions and standard work
Partner with other business segments: sales/marketing, customer service, engineering, quality, and finance
Understand customer needs and the core business markets we serve
Ensure business systems are implemented, maintained, and functioning properly
Participate in required company meetings
Maintain an organized work area (5S)
Participate in the Operational Excellence Program
Complete all other work duties as assigned
Ability to work in a manufacturing environment
Qualifications
Bachelor's Degree in Mechanical, Industrial, or in another Engineering Science
6 years of experience in engineering in a machining or manufacturing setting
Knowledge of quality systems, regulatory requirements, and industry standards
Advanced knowledge of blueprint reading and GD&T
Ability to operate and train to a variety of inspection equipment
Statistical expertise with DOE and Capability Studies
Design software- Minitab
Process management
Ability to consistently achieve short and long-term business results
Experience with ERP and quality systems
Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint, Publisher)
Clear and effective verbal and written communication skills
Attention to detail
Organizational skills
Ability to work in a fast-paced team environment
Ability to prioritize and multitask
Desirable Criteria & Qualifications
Experience in injection molding
Experience in the med device industry
