Quality Engineer

Provide technical Quality Engineering support to USF processes and systems.

The Quality Engineer will manage all validation activities, provide quality engineering expertise to the internal and outsourced manufacturing processes, and support nonconforming product and Material Review Board systems. The QE will also provide guidance to the quality inspection team and draft quality and manufacturing procedures per ISO 13485 and 21 CFR part 820 requirements.

This is a highly technical position that requires a minimum of four years experience in Quality Systems for a medical product manufacturer, preferably in medical diagnostics or devices.

Candidates must have proven experience with FDA GMP/QSR, ISO and other regulatory standards related to medical devices. Other requirements include experience with statistical process monitoring and data analysis software, the ability to perform product testing and supply technical documentation, and strong software experience in all MS modules, including Excel. A four-year technical college degree is required. ARKRAY offers the chance to make a significant contribution in a team-oriented environment.

ARKRAY offers a competitive salary, commissions plan, and a full range of employee benefits including medical, dental, life, disability, and 401(k) retirement plan.

Email resume and salary requirements in confidence to: Apply@arkrayusa.com

www.ARKRAYUSA.com

EEO Employer