Senior Quality Engineer — Medical Devices Leader

Cretex Medical Component and Device Technologies; Brooklyn Park (MN); On-site; USD 91,000 - 136,000; Full time

Job summary

Cretex Medical is seeking a Quality Engineer III to provide QA support for manufacturing, define and improve quality practices, and mentor junior staff. The role emphasizes ASQ QE BOK areas, data analysis, and process validation within a medical device environment.

You will interact with multiple teams, drive CAPA and PFMEA activities, and help ensure compliance with ISO and related medical device requirements. A strong background in GD&T, DOE, and Minitab is essential.

Qualifications

• Bachelor’s Degree in Mechanical, Industrial, or related Engineering Science.
• 6 years engineering experience in machining/manufacturing.
• Knowledge of quality systems, regulatory requirements, and industry standards.
• Advanced blueprint reading and GD&T knowledge.
• Ability to operate and train on various inspection equipment.
• DOE and Capability Studies statistical expertise.
• Design software: Minitab.
• Process management experience.
• Able to achieve short and long-term business results.
• Experience with ERP and quality systems.
• MS Office (Outlook, Word, Excel, PowerPoint).
• Clear verbal and written communication skills.
• Attention to detail and organizational skills.
• Ability to work in a fast-paced team environment.
• Ability to prioritize and multitask.

Responsibilities

• Quality engineering support for manufacturing and project management.
• Develop inspection requirements; facilitate PFMEAs; resolve discrepant material issues; create and maintain control/inspection plans.
• Analyze data and identify improvement opportunities.
• Act as quality interface for production teams; respond to customer complaints using FMEA, CAPA, and trend analysis.
• Conduct audits; close audit findings; determine corrective actions.

Skills

Quality systems

GD&T

DOE

Statistical analysis

Blueprint reading

Inspection equipment

Minitab

ERP

MS Office

Communication

5S

Team collaboration

Education

Bachelor’s Degree in Mechanical/Industrial Engineering

Tools

Minitab

ERP software

MS Office

Job description

Cretex Medical is seeking a Quality Engineer III to provide QA support for manufacturing, define and improve quality practices, and mentor junior staff. The role emphasizes ASQ QE BOK areas, data analysis, and process validation within a medical device environment.

You will interact with multiple teams, drive CAPA and PFMEA activities, and help ensure compliance with ISO and related medical device requirements. A strong background in GD&T, DOE, and Minitab is essential.