Principal Quality Assurance Auditor

August 6

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pfm medical, inc.

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pfm medical, Inc. is a subsidiary of pfm medical ag (Cologne, Germany) and was established in 2001 to serve as headquarters for North, Central, and South American development, manufacturing, marketing, and distribution activities$1. .$1

Medical Device Manufacturing

11 - 50

Description

• Responsible for providing senior oversight and subject matter expertise to quality and compliance activities supporting clinical studies

Requirements

• 5 years of experience • Working knowledge of GCP/ICH guidelines and FDA regulations and standards • Audit experience conducting a variety of audit types, including internal systems, vendors, TMF and investigator site audits. • Bachelor’s degree in a science, healthcare, or related field of study; combination of qualifications and equivalent relevant experience may be accepted as an alternative • Availability to travel up to 25% domestically and/or internationally

Benefits

• Discretionary annual bonus • Health insurance • Retirement savings benefits • Life insurance • Disability benefits • Parental leave • Paid time off for sick leave and vacation