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Quality Engineer

Skills Required :

  • Maintain company compliance with FDA Quality System Regulations and ISO 13485 standards. 
  • Actively participates in internal audits, management review and other activities covered under Lake Region Medical’s 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
  • Develops 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
  • Lead 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
  • Direct support for FDA and ISO inspections and registration
  • All other duties as assigned
  • Support and Participate in Continuous Improvement activities
  • Support and Participate in activities that increase the ratio of value added to non-value added processes
  • Demonstrates leadership through mentoring of junior staff and responsiveness to business needs to achieve positive results
  • Demonstrates technical ability through the application of engineering skills, approaches and knowledge

 

 

Qualifications

  • 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 not limited to presentation, organizational and management skills
  • Bachelors in Biotechnology or Biomedical Engineering

 


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