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Quality and Regulatory Manager

Peachtree Corners, GA 30092 | Permanent Hire

Job ID: 7690 Industry: Industry Pay Rate: 90,000

Quality and Regulatory Manager

Are you a hands on, experienced Quality and Regulatory Manager with a background in regulated industries? Are you located within commuting distance of the Northside of Atlanta ~ just OTP? If you are looking for a great working environment, then keep reading!

Top Reasons to Work for our Client?
  • 100% growth in four years.
  • Strong commitment to employees ~  Strong commitment to customers.
  • Global operations with 50+ years providing medical device products to a highly desired niche market

What you will be doing?
  • Perform quality control for finished products from parent company.
  • Responsible for quality contract on raw materials, packaged items, sterilization processing and final product release
  • In accordance to FDA’ s 21 CFR 820, follow, maintain, and advance the existing quality management system
  • Create procedures and work instructions associated to the quality management system
  • Responsible for cleanroom monitoring for air, product and personnel hygiene
  • Responsible for operational and production controls
  • Manage and participate in failure and improvement processes
  • Responsible for Training Program
  • Maintain records associated to device design, manufacturing, and distribution
  • Execute FDA regulatory activities including registration, listing and Medical Device Reporting
  • Perform US state device and drug licensing activities
  • Act as the main contact during FDA audits and ongoing communications

What you need for this position?
  • BS or Master in Science or Engineering
  • 5+ years of experience in a Quality role ~ prefer experience within an FDA regulated environment (medical device industry preferred)
  • Knowledge of FDA’ s 21 CFR 820 and US state drug/device licensing requirements
  • Prior experience writing and following approved procedures
  • Must be willing to be hands on and help in various ways with routine functions.

What’ s in it for you?
  • Excellent compensation, including bonus program  and complete  benefits package
  • Outstanding holiday and vacation plans
  • Great team-oriented environment that offers the opportunity to be hands on!

Send resume to Amy Szuba at aszuba@careertransllc.com

#awesomejobcth

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