Quality Engineer III

ID# DCCA25575

dinaliC is an international consulting firm specialized in projects for numerous industries. We are dedicated to provide contract and permanent opportunities for skilled professionals in their area or areas of expertise

JOB OVERVIEW 

Job Description and Responsibly 

  • Provide Quality System Regulatory interpretation, consulting, training, and assessment of the organization to ensure product teams are aligned with current regulatory requirements, standards, and current industry trends. 
  • Make technical decision on product fitness for reliability and guides the product team towards their goal and drives reliability implementation for products and demonstrates leadership abilities to drive reliability implementation for products 
  • Ensure that documented evidence exists to provide a high degree of assurance that specific design and processes will consistently and continually produce a product, meeting its current specifications and quality attributes. 
  • Lead project teams to utilize risk management and process excellence tools and effectively drives reasonable and appropriate risk controls. 
  • Lead, support and conduct product design verification, and product and process validation activities. 
  • Conduct or support failure and complaint investigations. 
  • Initiate and support continuous process improvements within area of responsibility, and conducting supplier quality system and product audits. 

Job Qualifications 

  • A minimum B.S. in Electrical, Mechanical or Biomedical Engineering or equivalent with 5 - 7 years of related experience. 
  • Strong quality engineering skills with working knowledge of: product design verification and product and process validation activities. 
  • Solid understanding of appropriate Risk Management regulations and guidance standards, such as, ISO 14971 and FDA Guidance and thorough understanding in the application of risk management tools, such as, Risk Analysis, FMEA and FTA. 
  • Working knowledge of both risk analysis and identification of effective risk controls. Ability to assess products, projects and activities using process excellence tools to determine risk-benefit balance with regard to clinical/patient, business/commercial, regulatory and technical risks. 
  • Strong working knowledge of using Risk Analysis, FMEA and FTA tool. 
  • Ability to utilize knowledge of Human Factors and Design during the design and evaluation of products 
  • Strong working knowledge of FDA QSR 21 CFR 820 / ISO13485 quality system requirements. 
  • Ability to provide an expert knowledge of both regulatory requirements and other compliance areas to minimize risk across franchise 
  • Ability to use problem solving techniques including root cause analysis and cause and effect analysis, Statistical techniques and methods. 
  • Ability to integrate Reliability techniques as a part of Product Development or Design Changes. 
  • Ability to demonstrate leadership abilities to drive risk management and reliability implementation for products. 
  • Ability to effectively utilize knowledge of Qualitative Reliability Techniques (such as dFMEA, pFMEA, DFx), Environmental Qualitative Reliability Tests (HALT and HASS) and Reliability Prediction and Ongoing Reliability Test (ORT). 
  • Working knowledge of Microsoft office products (Word, Excel, Access, and Project). Excellent written and oral communication skills 

The qualified candidate for this hands-on position should be able to use Quality Engineering principles, tools, and practices to develop and optimize systems and processes that are aligned with the overall business and quality vision. The individual must be capable of working independently and in a team setting supporting the new Product Development or Design Changes.

Position Details:

Medical Device

Engineering

Start Date: 
8-19-2013
End Date: 
12-31-2013

IRVINE, CA

CON_W2

40

DCCA25575

No

No