Medcomp is searching for a seasoned dynamic hands-on QA / QC Director that has a high-level of knowledge and experience in the following areas: EU MDR, Sterilization, Medical Devices,QMS, Laboratory Testing, FDA, ISO, MDSAP among other guidance, requirements and regulations to join and lead our Quality TEAM.
Qualified candidates must possess 7+ years related quality experience in a development and manufacturing environment. This position leads, manages and oversees all aspects of the Quality Assurance and Compliance and Quality Control activities while providing management support to our Analytical Lab.
Candidates should bring with them strong knowledge and experience with EU MDR, FDA and ISO regulations.
BS degree at minimum in a related quality, management and/or science discipline is required. ASQ certification and Six Sigma certification is preferred.
About Medical Components, Inc.
Medical Components, Inc. was founded in 1978 to manufacture and market vascular access catheters for acute hemodialysis. At that time catheter designs were simple, consisting of a single lumen catheter for single-needle dialysis or double lumen catheters for continuous-flow dialysis. As the need for new products grew with the advent of increasingly complex procedures, Medcomp emerged as a premier developer of innovative devices using our in-house staff of engineers, working in conjunction with some of the preeminent physicians in the field of nephrology and vascular access.
Building on our pioneering Tesio®, Split Cath®, and Duo-Flow® products, Medcomp continues to dominate the market in both new and proven dialysis, interventional, and accessory devices. Today our contributions to the medical device field total more than 70 product lines and thousands of distinct products, most notably and recently including the Pro-PICC® catheter and Dignity™ ports, which are both CT injectable.
To better support our professional clients, we began a successful transition in 2006 from a distributor-based sales system to a direct-sales force populated by highly skilled, clinically traine...d sales professionals. Medcomp is and will continue to be a stable, financially sound, privately held company wholly dedicated to the satisfaction of patients, its customers, and its team members at every level.