The growth continues for an orthopedic division located on Florida’s gulf coast. This division is part of a large corporation serving the medical device industry. They are continuing to invest in new equipment., software and technology as sales increase. There have been many internal opportunities for career growth for their valued associates. This division offers 100% paid healthcare, dental, vision and life insurance for their employees. They also have a 401K with company match, paid time off, paid holidays and many more benefits. This is a modern world class facility with a wealth of quality and testing equipment. They provide relocation assistance and paid travel cost to interview. Our firm has made many successful placements over the years. They have longevity among their team members who enjoy a collaborative work environment.
We are searching for a Quality Engineer with experience working in a FDA / ISO-13485 certified facility. The Quality Engineer will participate in the design and development of new products ensuring that designs meet all quality requirements. Experience reading prints and knowledge of Gd&T with the ability to communicate dimensional data is needed. The Quality Engineer develops inspection and gauging criteria and methodology. Past experience validating machinery processes and documenting IQ OQ PQ protocols. The Quality Engineer is responsible for analyzing statistical data, approves / communicates internal document change, creates / manages engineering change orders, creates non-conforming part reports and assists in the disposition of material. This position will document travelers, inspection sheets, work instructions and quality reports. The Quality Engineer interacts with customers, suppliers, vendors, skilled machinists, process engineers, production and management, strong problem solving skills using advanced methodologies to identify and close out customer complaints and corrective actions. The Quality Engineer will manage gauge calibration, train associates in the use of gauges and measuring tools. Good metrology skills using calipers, micrometers, depth gauges indicators, plug, thread, go and no go gauges. Candidates who have worked in a medical machining, aerospace or highly regulate machining environment are preferred. Knowledge of computers, software, basic math, project management and setting priorities is required.
MUST HAVE: a Bachelors degree, 5 years of quality engineering and/or equivalent experience in a highly regulated machining environment. Strong metrology, gauging, Gd&T and documentation skills are needed. Experience in a medical, orthopedic, medical machining and FDA / ISO-13485 certified environment is needed.
Keywords related to position:
ISO-13485, 13485, ISO13485, FDA, medical devices, surgical instruments, surgical implants, medical implants, orthopedic, orthopaedic, surgical tools, bone screws, joint replacement, hp, knee ankle, elbow, wrist, dental implants, fixation plates, medical machining, IQ OQ PQ, equipment validation, process validation, validations, spinal implants, medical implants, GMP, regulatory spine, orthopedic manufacturing, FDA CFR 21, FDA CRF part 820, medical machining, contract manufacturing, medical components, CAPA, endoscopy
Medvec Resources Group is a world-class technical and industrial recruiting firm specializing in a broad range of production machining and metal forming industries.