Quality Engineer – Medical Devices & ISO 13485

MGS Mfg. Group; Town of Germantown (WI); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401K plan

Paid vacation and holidays

Job summary

A leading manufacturing company in Germantown is seeking a Quality Engineer to enhance quality systems for medical products. In this role, you'll develop procedures and resolve quality issues while ensuring compliance with ISO standards. The ideal candidate has a BS in Engineering or a related field and experience in a regulated manufacturing environment. Excellent communication skills and expertise in quality tools are essential. Join us to support innovations that improve lives!

Qualifications

• Experience in a quality engineering role within a regulated manufacturing environment is preferred.
• Understanding of regulatory requirements: ISO 9001, ISO 13485, 21 CFR Part 820.
• Greenbelt Certification is a plus.

Responsibilities

• Assist with the development of quality systems and procedures.
• Monitor Corrective Action System and initiate investigations on complaints.
• Support Manufacturing process and train personnel on inspection techniques.

Skills

Quality standards understanding

Interpersonal communication

Continuous improvement projects

GD&T experience

Education

BS in Engineering, Quality, or related technical field

Tools

Microsoft Office products (Excel, Word, PowerPoint)

Job description

A leading manufacturing company in Germantown is seeking a Quality Engineer to enhance quality systems for medical products. In this role, you'll develop procedures and resolve quality issues while ensuring compliance with ISO standards. The ideal candidate has a BS in Engineering or a related field and experience in a regulated manufacturing environment. Excellent communication skills and expertise in quality tools are essential. Join us to support innovations that improve lives!