Quality Technician



Advert ID



Maple Grove

Job Type




Salary Range


No. of Openings


Branch Information

Minnesota Engineering - (USA) 3600 Minnesota Drive Suite 850 MN Edina , MN 55435



Job Description

Quality Technician | Direct Hire | $26-$30/HR | Maple Grove, MN | Medical Device Industry | 1st Shift

Quality Inspection Support

* Performs visual and dimensional inspections and evaluations of components and devices according to product specifications.

* Complete First Article Inspections and supporting documentation.

* Maintain accurate and up to date records of all materials. These activities are conducted during incoming receiving, in-line inspections, returned materials, etc.

* Assist in the development and improvement of product assurance systems such as incoming and in-process quality control, statistical process control, nonconformity controls, product lot release testing, and finished goods control.

* Manufacturing Support

* Assist with quality issues on the production floor.

* Assist in developing or changing manufacturing process instructions.

* Document non-conforming events and quarantine impacted material.

* Assist in the investigation and disposition of non-conforming material.

* Perform product release testing.

* Review device history records and acceptance records.

Quality Systems

* Perform various quality assurance tasks such as review of quality records, including lot history records, and returned product records.

* Create and update quality system documents such as systems procedures in accordance with ISO 13485:2016 and FDA regulations.

* Maintenance of quality system records and files as required.

* Assist or perform investigations such as CAPA or Nonconformance investigations.

* Perform review of quality records to ensure GDP requirements are met.

The ideal candidate will possess the following Experience, Knowledge and Skills:

* 2+ years of work experience in the medical device industry.

* Experience with ISO 13485, and FDA 21 cfr part 820.

* Proficient computer skills (MS Office, Excel).

* Good verbal and written communication skills. Must be detail oriented and able to work independently.


-High School Diploma

-Ability to read blueprints (able to determine what requirements are & need to do for incoming inspections

-GDP how to use measurement tools

-Medical Device industry experience