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Quality Compliance Engineer

Company: Alfa Wassermann
Location: Caldwell
Posted on: September 16, 2021

Job Description:

One of our mid-sized medical device clients are looking for a quality compliance engineer to join their team. This role is open due to an influx of business needs and in order to keep up with demand. This role will entail completing internal audits for all medical devices, working with suppliers to complete complaints investigations, teaching and reinforcing GMP trainings with all employees, and conducting corrective & preventative action. This individual will also help to formulate SOPs, review change authorizations, and represent quality for design controls and validation activities. This role will require someone with prior medical device experience.


-Experience with blood analyzers or other diagnostic medical devices
-BS Degree in either science or engineering (associates acceptable with ample quality compliance background)

-3+ years' experience within quality compliance engineering

-Working knowledge of 21CFR820, ISO 13485 and 14971

-Experience working in an FDA environment

-Experience with Medical Devices

Keywords: Alfa Wassermann, New York , Quality Compliance Engineer, Other , Caldwell, New York

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