Quality Engineer III - Molding

Career Crunch; Brooklyn Park (MN); On-site; USD 85,000 - 115,000; Full time

Job summary

Career Crunch is seeking a Quality Engineer III to support manufacturing quality assurance. The role defines, implements, and improves quality practices and provides technical guidance and measurement methodologies.

You will lead inspections, PFMEAs, CAPAs, audit activities, and mentor junior engineers while aligning with ISO and medical device requirements. A strong background in GD&T, DOE, Minitab, and ERP systems is essential.

Qualifications

• Bachelor's degree in Mechanical, Industrial, or Engineering Science.
• 6 years of engineering experience in a machining/manufacturing setting.
• Knowledge of quality systems, regulatory requirements, and industry standards.
• Advanced knowledge of blueprint reading and GD&T.
• Ability to operate and train on inspection equipment.
• Statistical expertise with DOE and Capability Studies.
• Design software – Minitab.
• ERP and quality systems experience.
• Microsoft Office proficiency.

Responsibilities

• Quality engineering support for manufacturing and project management.
• Develop inspection requirements; PFMEAs; resolve discrepant material issues and create/maintain quality documents 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 and CAPA/trend analysis.
• Conduct audits and close out audit findings with corrective/preventive actions.
• Coach and mentor Quality Engineer levels I and II.
• Lead and participate in large company projects providing quality recommendations.
• Support Quality Inspectors to ensure inspection plans meet customer requirements.

Skills

Quality systems

DOE

GD&T

Statistical analysis

ERP systems

Communication

Team leadership

Education

Bachelor's Degree in Mechanical, Industrial, or Engineering Science

Tools

Minitab

MS Office

Job description

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