Senior Quality Engineer - Molding (Med Device)

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

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.