181 Quality Engineer (181 QE) 

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 will play a key roll in the support of quality control and manufacturing activities, including product stability programs. An exciting opportunity available for the individual selected will be a key roll in the design and qualification of their new manufacturing facility (aseptic and non aseptic processing of biologic/device combination products). In addition this position will oversee studies related to product, packaging, distribution and stability including protocol generation, study execution/coordination and report writing and will also be responsible for managing the stability programs at contract testing facilities.

Position Requirements: 

·  BS degree in a technical discipline such as engineering, biology, biochemistry, etc. CQE or equivalent experience strongly preferred ·  At least 4 years experience in a GMP or QA environment·  Prior experience with aseptic process, medical devices or QC operations and experience with facility, systems, process equipment qualification, and DOE required

·  Strong proficiency with GMP and device regulations in the
US and EU

·  Excellent analytical, decision making and problem solving skills along with strong verbal and written communication stills

·  A strong desire to work in a highly interdependent, fast paced, small company environment

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