Quality Engineer II - Medical Manufacturing

Express Employment Professionals - Edina; Brooklyn Park (MN); On-site; USD 70,000 - 100,000; Full time

Job summary

Express Employment Professionals - Edina is seeking a Quality Engineer II to provide quality assurance support for manufacturing, define and improve quality practices, and guide measurement methodologies. You will develop inspection requirements, facilitate PFMEAs, resolve discrepant material issues, generate control and inspection plans, and analyze data to identify improvements.

The role also involves leading audits, supporting process validation, CAPA activities, and ensuring ISO/medical

Qualifications

• Bachelor's degree in Mechanical, Industrial, or related Engineering field.
• 3 years of engineering experience in machining or manufacturing.
• Knowledge of quality systems, regulatory requirements, and industry standards.
• Intermediate blueprint reading and GD&T knowledge.
• Ability to operate a variety of inspection equipment.
• Statistical methods including DOE and capability studies.

Responsibilities

• Quality engineering support for manufacturing and project management.
• Develop inspection requirements; facilitate PFMEAs; resolve discrepant material issues and create/maintain control and inspection plans.
• Analyze data and identify improvement opportunities.
• Act as the quality interface for production teams handling customer complaints with failure analysis and CAPA.
• Conduct audits and close out findings with corrective/preventive actions.
• Lead and participate in projects providing quality recommendations.
• Support validation of processes, equipment, and metrology.
• Create protocols and analyze data.
• Support Quality Inspectors to ensure inspection plans meet customer requirements and comply with ISO and medical device standards.

Skills

Quality engineering

GD&T

DOE

Data analysis

Education

Bachelor's Degree in Mechanical or Industrial Engineering

Tools

Inspection equipment

Job description

Position Summary

The Quality Engineer II 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
• Lead and participate in intermediate company projects providing quality recommendations
• 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
• Support and comply with the company Quality System, ISO, and medical device requirements
• Read, understand, and follow work instructions and standard work

Qualifications

• Bachelor's Degree in Mechanical, Industrial, or in another Engineering Science
• 3 years of experience in engineering in a machining or manufacturing setting
• Knowledge of quality systems, regulatory requirements, and industry standards
• Intermediate knowledge of blueprint reading and GD&T
• Ability to operate a variety of inspection equipment
• Statistical expertise with DOE and Capability Studies