Quality Engineer II - Medical Device Manufacturing

Cretex Medical Component and Device Technologies; Minneapolis (MN); On-site; USD 75,000 - 113,000; Full time

Benefits offered by this job

401k with company match

Onsite health clinics

Cretex University

Discretionary holiday bonus

Job summary

Cretex Medical is seeking a Quality Engineer II to provide quality assurance support for manufacturing. You will define, implement, and improve quality practices and provide technical guidance and measurement methodologies across the production teams.

Key duties include developing inspection requirements, conducting PFMEAs, resolving discrepancies, performing data analysis, and supporting audits and CAPAs in a fast-paced environment.

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.
• Design software- Minitab.
• Process management and ERP experience.
• Proficiency with Microsoft Office and strong communication.
• Attention to detail and strong organizational skills.

Responsibilities

• Quality engineering support for manufacturing and project management.
• Develop inspection requirements; facilitate PFMEAs; resolve discrepant material issues and create and maintain quality documents.
• Analyze data and identify improvement opportunities.
• Respond to customer complaints using FA, CAPA, and trend analysis.
• Lead and participate in intermediate company projects with quality input.
• Support validation of processes, equipment, and metrology; create protocols and analyze data.
• Ensure inspection plans meet customer requirements and ISO/medical device standards.
• Collaborate across sales/marketing, customer service, engineering, quality, and finance.

Skills

Quality engineering

GD&T

Blueprint reading

DOE

Minitab

ERP

Microsoft Office

Data analysis

Inspection equipment

Education

Bachelor’s Degree in Mechanical/Industrial Engineering

Tools

Minitab

ERP systems

Job description

Cretex Medical is seeking a Quality Engineer II to provide quality assurance support for manufacturing. You will define, implement, and improve quality practices and provide technical guidance and measurement methodologies across the production teams.

Key duties include developing inspection requirements, conducting PFMEAs, resolving discrepancies, performing data analysis, and supporting audits and CAPAs in a fast-paced environment.