Quality Engineer II — Medical Device QA & Process Excellence

Regulatory Jobs; Brooklyn Park (MN); Presencial; USD 75.000 - 113.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

401k plan

Onsite health clinics

Discretionary holiday bonus

Cretex University

Employee assistance program

Wellness program

Life insurance

Paid holidays

Descripción de la vacante

Cretex Medical in Minnesota is seeking a Quality Engineer II to provide QA support for manufacturing. You will define, implement and improve quality practices, guiding measurement methodologies and acting as the quality interface for production teams.

Responsibilities include PFMEAs, audit leadership, data analysis, and CAPA development. The role requires a Bachelor’s in engineering, 3 years in manufacturing, and strong knowledge of quality systems and regulatory standards.

Formación

• Bachelor’s degree in Mechanical, Industrial, or related Engineering.
• 3 years engineering experience in machining/manufacturing.
• Knowledge of quality systems and regulatory standards.
• GD&T and blueprint reading proficiency.
• Experience with ERP and quality systems.
• Proficiency in Microsoft Office.

Responsabilidades

• QA support for manufacturing and project management.
• Develop inspection plans and PFMEAs; drive corrective actions.
• Analyze data to identify improvement opportunities.
• Interface with production to respond to customer complaints.
• Lead audits and close out findings with CAPAs.
• Support validation of processes, equipment, metrology.
• Maintain ISO and medical device compliance.

Conocimientos

Quality engineering

DOE & SPC

Blueprint reading

GD&T

Inspection equipment

ERP experience

MS Office

Communication skills

5S

Educación

Bachelor’s Degree in Mechanical, Industrial or related Engineering

Herramientas

Minitab

Descripción del empleo

Cretex Medical in Minnesota is seeking a Quality Engineer II to provide QA support for manufacturing. You will define, implement and improve quality practices, guiding measurement methodologies and acting as the quality interface for production teams.

Responsibilities include PFMEAs, audit leadership, data analysis, and CAPA development. The role requires a Bachelor’s in engineering, 3 years in manufacturing, and strong knowledge of quality systems and regulatory standards.