Quality Engineer
Location: Brooklyn Park, Minnesota
Description: Indrotec is hiring Quality Engineer right now, this occupation will be presented in Minnesota. Further informations about this occupation opportunity please read the description below. Inginaire is seeking a talented Quality Engineer for an exciting contract to hire opportunity in Brooklyn Park. Quality assists in the design and implementation of policies and procedures for testing and evaluati! ng 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.
Take a look at the day to day responsibilities and apply right! away if this interests you. Feel free to call 612.977.1450 fo! r more information.
Maintain company compliance with FDA Quality System Regulations and ISO 13485 standards
Experience with FDA and ISO inspections and registration is a plus
Actively participates in internal audits, management review and other activities covered under the Quality Manual, Policies and Procedures
Provide customer-related quality and regulatory inquiries’ support
Compiles and writes training material and conducts training sessions on quality control activities
Provide QE direction, analysis and recommendations for Product Development to successfully launch new products into active production in a timely and cost effective manner Directs development and maintenance of internal/external standards relative to Design and Development,
Lead implementation of continuous improvement projects or act as subject matter expert for SPC, FMEA, DOE and process validation
Lead and provide Project Management support as needed
Develop! s and initiates standard methods for inspection, testing, and evaluation, utilizing knowledge in related engineering fields
Devises sampling procedures and designs and develops forms and instructions for recording, evaluating, and reporting quality and reliability data
Performs measurement system analyses to evaluate test and inspection equipment
Leads disposition of discrepant material and devises process to assess product quality and reliability.
Monitors and directs engineering group on calibration requirements and implementation of systems to support equipment calibration
Support supplier approval and qualification of new/revised items which includes inspection method development and validation as well as correlation with supplier’s methods, supplier audits, management of supplier corrective and preventative actions and assist in FMEA
Support for FDA and ISO inspections and registration
Supports or may perform measuring, testing, and tabula! ting data concerning quality and reliability
All other duties as as! signed
Expected Qualifications:
2-7 years experience in the Medical Device or other regulated industry, such as QSR and ISO 13485, with increasing responsibility
Experience with FDA and ISO 13485 Certification inspections is a plus
Must be adept in use of computer software for the analysis of data, preferably Microsoft Excel and statistical packages (Minitab preferred)
Quality Engineering certification (CQE) preferred or equivalent body of knowledge in areas which include but are not limited to Statistics, SPC, Geometric Dimensioning & Tolerancing; Sampling, Design of Experiments, etc. Ability to analyze, understand and effectively communicate this technical material. Experience with Lean Manufacturing and Six Sigma is a plus
Ability to organize and judge priorities in a dynamic, fast-paced environment and work independently with minimal supervision
Must possess excellent verbal & written communication skills, which include but are no! t limited to presentation, organizational and management skills
Bachelors Degree
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If you were eligible to this occupation, please email us your resume, with salary requirements and a resume to Indrotec.
Interested on this occupation, just click on the Apply button, you will be redirected to the official website
This occupation will be opened on: Tue, 01 Oct 2013 05:38:17 GMT