Looking for a QE and a Production Planner at Lake Region in Brimfield ~ Apply on the site - or send me a note ~ Quality assists in the design and implementation of policies and procedures for testing and evaluating the precision and accuracy of products and/or equipment. The Quality Engineer will be expected to provide support to Operations, interact with customers and provide support for Engineering, Quality Systems and Process engineering. Specializations may include but are not limited to: design control; material and process control; product reliability; software quality engineering; and/or metrology. This position will be integral in meeting the Quality Management System requirements. It requires creativity and foresight to work with operations and product development teams to ensure compliance to the Quality Manual, Design Control, Supplier Management and other appropriate procedures for a variety of medical devices from concept through market introduction. The ideal candidate is a self-motivated individual who is excited by the prospect of working in a dynamic, fast-paced environment. Responsibilities: •Comply with FDA Quality System Regulations and ISO 13485 standards. Attends training sessions on quality control activities. Supports internal audits, management review and other activities covered under Lake Region Medical Quality Manual, Policies and Procedures. •Provide customer related quality and regulatory inquiries support, such as assistance with corrective and preventative actions closure and FMEA as well as complaint analysis. •Facilitate execution of IQ’s, OQ’s and PQ’s to ensure compliance with the Quality System. Provide data analysis and other tasks to support the transfer of product/process changes into manufacturing in a timely and cost effective manner. •Support implementation of continuous improvement projects using tools such as SPC, FMEA and DOE. Engages in measuring, testing, and tabulating data concerning quality and reliability. Knowledge of precision instrument use, analytical testing and/or performance testing is a plus. •Participates in supplier approval and qualification of new/revised items which includes First Article Inspections. Performs inspection, testing, and evaluation, utilizing knowledge in related engineering fields. •Complies with all work rules including those pertaining to safety, health, quality, QSR’s and the Lake Region Medical Quality Management System. Desired Skills and Experience Required Skills: Requirements: •BS Engineering (Mechanical Engineering preferred) •Lean Manufacturing, continuous process improvement experience desires. Six Sigma certifications desired. •Basic knowledge of computer software for the analysis of data, specifically Microsoft Excel and statistical packages (Minitab preferred), is a plus. •Quality Engineering certification (CQE) or equivalent body of knowledge is a plus in areas which include, but are not limited to, Statistics, SPC, Geometric Dimensioning & Tolerancing (preferred); Sampling, Design of Experiments (DOE). •Validation experience (IQ/OQ/PQ) preferred or PPAP, AQPQ. •Able to organize and judge priorities. •Must be an effective communicator, which includes presentation and technical writing skills. •Basic knowledge of computer software for the analysis of data, specifically Microsoft Excel and statistical packages (Minitab preferred), is a plus. •Ability to read mechanical drawings, blueprints preferred. •Minimum travel
Posted on: Mon, 19 Jan 2015 23:56:19 +0000
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