This position is responsible for ensuring compliance with Federal, State and local regulations pertaining to GMP/QSR, ISO9001/ISO13485/CMDR/CE and associated regulatory agencies through effective management of complaints process. In this position you will be responsible for directing personnel and maintaining all activities associated with customer complaints. Working closely with the Customer Service and Field Service groups to process all customer service issues and to identify customer complaints, as required by FDA, Canadian, European and International regulations related to medical device manufacturers and will maintain all complaint and complaint investigation files according to company's quality system requirements.

Requires a four-year college degree in science, math or related field and 8 years related experience. Strong knowledge of FDA regulations and ISO standards. Certifications from ASQC, CQE, etc., preferred. Strong writing skills. Proficient in standard software applications. Crystal Reports and general knowledge of database configuration helpful. Communication skills both verbal and written.

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