DIRECTOR OF QUALITY ASSURANCE (medical device)
Our client is a well-funded, early stage diagnostic instrument developer. Using proprietary biosensor technology, they are revolutionizing the point-of-care (POC) diagnostics industry. The Director of Quality Assurance will be key player in their continued growth including leading the ISO 13485 certification initiative and expanding the supply chain quality initiatives already underway.
The ideal candidate will have 10+ years progressive quality management experience in medical devices, preferably diagnostics. A blend of large company/small company experience is also preferred. BS degree in science or engineering, Master's preferred. Must have strong knowledge of US and EU regulations including ISO 13485, 21CFR820, EN46001, and MDD (Medical Device Directive). Professional certifications strongly preferred.
Base salary, bonus, equity, strong benefits package. Interested candidates should submit a resume and cover letter via email to Bruce Rudolph, Principal , The Carleton Group Executive Search, for immediate consideration.