Quality Engineer

Title: Quality Engineer (I or II)
Salary: $75k-$105k
Location: Columbus, MN area (Northern Twin Cities Suburbs)

Essential Duties: 

• Develop and analyze in-process data to provide trend analysis to troubleshoot quality issues and provide recommendations to internal and external customers. 
• Establish qualification and validation plans, execute, and document the results via reports in accordance with company and customer requirements in support of new product development. As well as existing product line maintenance. 
• Drive quality related investigations of assigned product line failures to resolution. Own any quality system records (CAPA, NC, Complaint) associated with the assigned product lines. 
• Assist project teams in developing risk management and control plans for products to ensure that the proper controls are in place so that the products we produce meet customer expectations. 
• Identify opportunities to implement SPC to improve the in-process controls currently in place. 
• Identify opportunities for improvement, including systems and product improvements, in the assigned areas. 
• Other duties as assigned. 

Qualifications:

• Bachelor’s degree
• Certified Quality Engineer (CQE) preferred.
• Valid identification and the ability to work legally in the United States.
• 2+ years of experience, preferably in a Medical Device or Component manufacturing environment 
• Excellent written and oral communication skills (including data interpretation and reporting) 
• Problem Solving and Critical Thinking to evaluate options and implement solutions 
• PPAP, IQ, OQ, PQ, FMEA, CONTROL PLANS, DOE, GRR, risk management, problem solving 

Due to ITAR regulations, this role is only open to U.S. Citizens, lawful permanent residents (green card holders) or foreign nationals granted refugee or asylee status. Individuals with temporary visas (e.g. E, F-1, H-1, H-2, L, B, J, TN or OPT) are not eligible for hire in this role.