Manager FDA Quality Assurance -no health insurance provided - Pay to
- Employer
- Gables Search Group
- Location
- Pewaukee
- Salary
- 120000.00 USD Annual
View more
- Industry
- Healthcare
- Role
- Manager
- Job Type
- Long-Term
- Hours
- Full Time
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Manager of FDA Quality Assurance No health insurance provided by the employerNo remotePay to $120,000Pewaukee, Wisconsin area This full time, permanent Manager of FDA Quality Assurance is at a niche manufacturer of devices and sensors that are utilized in the healthcare industry. The company is employee-friendly and family friendly. The company can be flexible with time off. The niche market for company products is in demand and there are no competitors. The company does not currently provide health insurance to employees. Duties and responsibilities include the following: Reporting to the company president Working with minimal supervision Leading quality and/or manufacturing process improvements Leading internal audits Working with ISO Working with FDA Reviewing various quality records Overseeing quality data collection Overseeing quality standard operating procedures and work instructions Overseeing quality system procedure maintenance Reviewing quality logs, complaints, corrective actions, change notices, SCAR and CAPA Overseeing quality metrics Presenting at meetings with management Overseeing internal quality and external supplier audits Training others Documenting The background of the successful candidate should include the following: A engineering, quality or business degree Two or more years of leading FDA quality inspections Two or more years of leading FDA quality audits Two or more years of experience with ISO applications Two or more years of experience with FDA applications Six or more years of related quality control experience Possess the ability to work at a company that does not provide health insurance Possess a solid work history Being a US citizen or green card holder Having a residence within a 45 minute drive
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