Quality Engineer II/III: Driving Medical Device Quality

Regulatory Jobs; Dassel (MN); On-site; USD 75,000 - 136,000; Full time

Benefits offered by this job

401k match

Onsite health clinics

Discretionary holiday bonus

Cretex University

Wellness program

Life insurance

Paid time off

Tuition assistance

Job summary

Cretex Medical is a leading contract manufacturer serving the medical device industry with capabilities in injection molding, laser processing, metal stamping and device assembly. This Quality Engineer role focuses on defining and improving quality practices, supporting manufacturing, and guiding cross-functional teams to address customer and process issues.

The position may be filled at Quality Engineer II or III level depending on experience, with salary ranges and benefits described in the

Qualifications

• Bachelor's degree in Mechanical, Industrial, or engineering science.
• Quality Engineer II: 3+ years in engineering in a machining or manufacturing setting.
• Quality Engineer III: 6+ years in engineering in a machining or manufacturing setting.
• Knowledge of quality systems, regulatory requirements, and industry standards.
• Intermediate blueprint reading and GD&T.
• Ability to analyze data and ensure data integrity.
• Ability to operate a variety of inspection equipment.
• DOE and Capability Studies (statistical expertise).
• Design software - Minitab (listed).
• Proficiency with Microsoft Office (Outlook, Word, Excel, PowerPoint, Publisher).
• Clear verbal and written communication skills.
• Attention to detail and organization.
• Ability to work in a fast-paced team environment.

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, corrective and preventive actions, and trend analysis.
• Conduct audits, including closing out audit findings, create audit finding reports and determine proper corrective and preventive 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.
• Partner with other business segments: sales/marketing, customer service, engineering, quality, and finance.
• Understand customer needs and the core business markets we serve.

Skills

Quality engineering

DOE

Data analysis

Blueprint reading

GD&T

Inspection equipment

Statistical methods

Education

Bachelor's Degree in Mechanical/Industrial Engineering

Tools

Minitab

Job description

Cretex Medical is a leading contract manufacturer serving the medical device industry with capabilities in injection molding, laser processing, metal stamping and device assembly. This Quality Engineer role focuses on defining and improving quality practices, supporting manufacturing, and guiding cross-functional teams to address customer and process issues.

The position may be filled at Quality Engineer II or III level depending on experience, with salary ranges and benefits described in the