181 Associate Director - Quality Systems (181 ADQE) 

Location: Nashville, TN

Our client is a regenerative medicine company committed to developing and marketing, worldwide, the highest quality therapeutic medical products for the treatment of conditions where bone regeneration is critical. Their goal is to be a world-leader in novel, therapeutic proteins used in the surgical treatment of selected conditions to include, but not limited to, oromaxilofacial, orthopedic, sports medicine, trauma, and spine. The Company is well-established, having just received FDA approval on its lead product and has established a marketing alliance with a major pharmaceutical company.

This position is responsible for the creation, support, and maintenance of the company’s quality systems, FDA and EU regulatory filings, supporting product development, operations, and quality control activities in accordance to FDA quality System Regulations (21 CFR Part 820), ANSI/ASQ Q9002: 1994, EN46001: 1994 ISO13485 and EU Medical Device Directives.

Position Requirements: 

Bachelor’s degree minimum; some graduate work preferred
A minimum of three (5) years experience within the regulated (Medical Device/Pharmaceutical) industry. Working knowledge and/or training in quality standards, such as ISO 9001 or FDA Quality System Regulations, essential.

Useful technical skills/knowledge base includes:

·  Auditing of manufacturing facilities;

·  Conducting analytical testing in conformance with GMPs;

·  Good Laboratory Practices Standards;

·  Microbiological testing to include issues of product sterility;

·  Standards and standard setting bodies to include:
1.ISO
2.AAMI
3.ASTM
4.ICH
5.USP

·  Computer skills to include Excel, MS Project, and Visio

You can email resumes to Admin@LegacyMedSearch.com 

ABOUT Legacy MedSearch:
Retained Recruiting Firm specializing in the Emerging Medical Technology. Our firm is hired by medical device and imaging manufacturers to find senior-level executives in specialized fields such as surgery, diagnostic & therapeutic imaging & radiology, including CT, MR, PET, DR/CR, Ultrasound, HIFU, Fluoroscopy, PACS, Mammography, MIS & LIS procedures. We work with manufacturers of a variety of implants & technologies: IMD, AIMD and Class I, Class II and Class III devices with special emphasis on orthopedics, Navigation (IGS, CAS, DBS, Surgical Robotics, NeuroScience), neurosurgery, radiology, neuroscience, cardiology and cardiovascular and other emerging medical technology (VC, PMA, 510(k) & IDE device classes).
Our office recruits: Product Managers, Engineers (Product Development, Design, Manufacturing, Electrical and Software engineers), Marketing and Sales Executives, Operations, Quality, Regulatory, Research Professionals.   In the past 18 months, we have placed 48 professionals in start-up, emerging & leading medical companies.For additional information, please visit our website at www.LegacyMedSearch.com