Quality Engineer - ISO-13485, medical device, manufacturing
Basic Job Info
Quality Engineer – ISO-13485, medical device, orthopedics, manufacturing
A medical device division of a large corporation continues to grow, invest in new technology and hire at multiple facilities. They manufacture orthopedic devices and surgical instruments. This division provides 100% paid medical, dental, vision and life insurance for the employees. They also offer 401K with company match, generous paid time off and relocation assistance. Our firm has made several successful placement of employees. They strive for employee development and internal promotions.
We are searching for a Quality Engineer with 5-10 years of manufacturing experience. Past experience working in a medical device / ISO-13485 certified environment is needed. FDA 21CFR820 experience is preferred. Our client may consider aerospace experience, AS-9100 and FAA knowledge. The Quality Engineer with reviewing new prints for tolerance, inspectability and quality of design issues, needing good GD&T. The Quality Engineer will create engineering change orders, inspection plans, interact/train in inspection associates, review/manage material certifications and manage gauge control. Strong document control and technical writing skills are needed. Candidates will need good metrology sills with the ability to use lab equipment, gauges and hand tools. The Quality Engineer will prepare inspection / test plans, work instructions, SOP’s and corrective actions. Strong problem solving skills using root cause and six sigma tools is needed. The Quality Engineer will address customer complaints, concerns and returns. Past experience investigating quality issues, identifying root cause and preparing CAPA is required. The Quality Engineer will work with customers, suppliers, vendors and internal associates involving corrective actions and product launches. Project management skills are strongly preferred. The ideal candidate will have manufacturing and/or worked in a machining, assembly and metal finishing environment. Past experience in a orthopedic and/or medical device manufacturing environment is preferred.
MUST HAVE: 5 years of Quality Engineering experience and minimum of 5 years of experience in manufacturing. Experience in a ISO-13485 medical device manufacturing environment is strongly preferred. FDA experience is a plus. Aerospace / FAA experience will be considered. Strong technical writing, documentation, MS Word and Excel are needed. Candidates with a Bachelors degree, Six Sigma Black / Green Belt and/or quality certifications are preferred. The ideal candidate will need Gd&T, metrology, problem solving and communication skills. Strong problem solving skills, development of corrective actions and experience developing CAPA is required.
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