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Manager FDA Quality Assurance - no health insurance provided

Employer
Affinity Executive Search
Location
Pewaukee
Salary
Competitive

View more

Industry
General
Role
Manager
Job Type
Long-Term
Hours
Full Time
MANAGER OF FDA QUALITY ASSURANCE
Candidates must have two or more years of experience leading FDA quality inspections andleading FDA quality audits
No health insurance provided by the employer
Pay to $120,000
Must be a United States citizen or Green Card holder
No remote
No relocation
Full-time
Permanent W-2 employee
Full benefits
Pewaukee, 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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