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Quality Systems Administrator

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.
Requirements:
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 Duties:
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 scheduleThe 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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