Medical Device Quality Inspector

Equiliem; Madison (WI); On-site; USD 35,000 - 55,000; Full time

Job summary

An established industry player is seeking a detail-oriented Medical Device Quality Inspector to join their dynamic team. This role involves inspecting parts to ensure they meet specifications using various measurement tools. The ideal candidate will have experience with optical measurement machines or CMM, and familiarity with ISO13485 or ISO 9001 standards. You will be trained in ERP systems like SAP and play a crucial part in maintaining quality integrity in a fast-paced manufacturing environment. If you are flexible, detail-oriented, and eager to contribute to a collaborative team, this opportunity is perfect for you.

Qualifications

• Experience with optical measurement machines and CMM is preferred.
• Ability to identify defects and work in a fast-paced environment.

Responsibilities

• Inspect parts to specifications using measurement tools.
• Ensure compliance with GMP standards and quality integrity.

Skills

Optical Measurement Machines

CMM

ISO13485

ISO 9001

Attention to Detail

Basic Math Skills

English Proficiency

Teamwork

Education

High School Diploma

Tools

Calipers

Micrometers

Gage Pins

Plug Gages

Thread Gages

SAP

Microsoft Word

Microsoft Excel

Job description

Medical Device Quality Inspector



Desired:

Experience with optical measurement machines or a CMM

Familiar with ISO13485 or ISO 9001



The Medical Device Quality Inspection group is responsible for assuring that materials, activities, processes, and specified conditions related to the daily device manufacturing, processing and packaging meet current GMP standards and comply with applicable procedures and standards such as to ensure the quality integrity of the product.



The medical device quality inspector inspects parts to specifications that are on a part drawing. This person will perform part inspections using measurement tools such as calipers, micrometers, gage pins, plug gages, and thread gages.

This person would also be trained to an ERP system; SAP to enter in acceptance data. Another system they would learn is the nonconforming material reports to enter failure data. I'd prefer someone who has material inspection experience as described and be able to work with computer based applications. They may not have SAP experience, but we will train. we are ISO 13485:2008 registered company as well as registered with the FDA. While this person may not have experience in a regulated environment they would be expected to follow procedures after being trained. We have a team environment and all of the team works together on supporting production which means being flexible on assignments. We also at times work overtime depending on production schedules and incoming part volumes.



Additional qualifications include:

High School diploma

Read and write in English

Basic math skills

Ability to use measurement devices such as calipers, thread gauges and micrometers to check whether materials or products meet standards

Ability to identify defects and flaws

Attention to detail

Ability to work in a fast paced team environment with minimal supervision

Work with Microsoft Word and Excel

Flexible in working overtime as needed #ZR