Nationwide Executive Recruitment From FPC

(F-O-R-T-U-N-E PERSONNEL CONSULTANTS)

You'll Value The Experience!

In this position you will be responsible for conducting compliance audits at our client’s facilities located in interesting and exciting locations in the US and throughout the world.  You will also plan and conduct requested audits of specific products, processes, or areas with the ability to apply and explain real world application of requirements, regulations and standards.  This successful individual will be responsible for working with QA management/teams on validation, protocol and process reviews and implementation of requirements in compliance programs.

Plan and conduct schedule corporate quality system audits to assess compliance with FDA, ISO, MDD and internal requirements encompassing both Medical Device and Pharmaceutical GMPs.

Audit Scheduling investigation and presentation of audit observations, findings and reporting.  And confirmation of follow-up actions.

Participate in planning, coordination, and implementation of corporate audit policies with corporate and division leaders.

The successful candidate will receive extensive, up-to-date training in order to review, understand and implement changes related to ISO, QSR and cGMP requirements.

Incorporation of this information into corporate and divisional programs through document reviews, protocol and validation reviews, training programs and participation with corporate and divisional QA on policy/procedures/guideline development.

Job Requirements:

• BS degree with 5 to 7 years experience in quality and regulatory for medical devices and pharmaceuticals.
• Must be able to travel up to 50% of the time domestically and internationally.
• Training in audit techniques and a comprehensive working knowledge of FDA regulations and ISO guidelines.
• Ideal requirements:  Minimum of five years experience in Compliance Auditing in medical device, pharmaceutical and/or a comparable related environment, certified auditor or lead auditor training.  Knowledge of anatomy and physiology would be helpful.