50,000 - 65,000 - Quality Systems Administrator - Berlin, WI

Berlin, WI
$50,000 - $65,000
Job Type
Direct Hire
Associate of Science

Our client has a new medical device division they are staffing up and they need to add a Quality Systems Administrator who will work for the Quality Manager and administer all quality programs to keep the company in FDA compliance. You manage the quality systems databases for SOPs, training, change controls, CAPAs, validations, etc. The plant is located near Berlin, WI. This is an excellent, well run organization.

Associates degree and 3 to 5 years or Bachelors' degree and 1 to 4 years of FDA quality compliance experience
Excellent communication skills, both written and verbal
Strong organizational skills and superb attention to detail and accuracy of work
Able to work with no supervision, be a self-directed multi-tasker
Excellent computer skills including Word, Excel, and e-mail
Excellent problem solving skills
Working knowledge of FDA,CFR Title 21, Part 820 and ISO 13485
Maintain the documentation related to a FDA compliant quality system
Support ATF quality system through data collection and analysis in support of continual improvement of product and process
Converting quality data into trends analysis and informational reports
Create clear and concise written documents and reports
Participate as a contributing member of the local leadership team
Key Metrics
Continued FDA registration
Continued ISO certification
Calibration takes place per the schedule
Response to customer complaints
Internal Audits are performed per schedule
The company offers a comprehensive benefits package and will assist with relocation expenses if needed. (In order to get a salary above $60,000 you will have a to bring more relevant skills to the position than are listed as minimums) Sorry, no visa sponsorship is available.

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