Quality Engineer II - Medical Device QA & Process Improvement

Cretex Companies, Inc.; Brooklyn Park (MN); On-site; USD 75,000 - 113,000; Full time

Benefits offered by this job

401k with company match

Onsite health clinics

Discretionary holiday bonus

Job summary

Cretex Medical in Minnesota seeks a Quality Engineer II to provide quality assurance support for manufacturing and project activities. You will help define, implement, and improve quality practices and provide technical guidance across processes.

The role requires a Bachelor’s degree in engineering and 3+ years in machining/manufacturing, with strong knowledge of quality systems, GD&T, DOE, and Minitab. Onsite work with a robust benefits package is offered.

Qualifications

• Bachelor's Degree in Mechanical, Industrial, or related Engineering Science.
• 3 years of engineering experience in machining or manufacturing.
• Knowledge of quality systems and regulatory standards.
• Intermediate blueprint reading and GD&T knowledge.
• Experience with ERP and quality systems.

Responsibilities

• Quality engineering support for manufacturing and project management.
• Develop inspection requirements; facilitate PFMEAs; resolve discrepant material issues and create and 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, 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.

Skills

Quality engineering

Data analysis

Communication

Team collaboration

Attention to detail

Statistical methods

Education

Bachelor’s Degree in Mechanical, Industrial, or in another Engineering Science

Tools

Minitab

ERP systems

Microsoft Office

Inspection equipment

Job description

Cretex Medical in Minnesota seeks a Quality Engineer II to provide quality assurance support for manufacturing and project activities. You will help define, implement, and improve quality practices and provide technical guidance across processes.

The role requires a Bachelor’s degree in engineering and 3+ years in machining/manufacturing, with strong knowledge of quality systems, GD&T, DOE, and Minitab. Onsite work with a robust benefits package is offered.