Quality Engineer III - Molding

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