Quality Engineer

East Bay, (none selected) | Direct Hire

Post Date: 06/01/2017 Job ID: JOS000006737 Industry: Software/Hardware

SUMMARY: Works on quality improvement projects that support lean manufacturing work-flow, (mostly of moderate scope where analysis of situation or data requires a review of identifiable factors). As a member of a Value Stream Group; participates in decisions on scope of work, design changes, improvements, adherence to specifications and standards, selection of equipment and length of tasks.

Provides technical, Quality and Lean manufacturing guidance to lower level personnel. Develops and maintains Quality Controls Metrics (Graphs, Charts, Tables, etc….)

 

EDUCATION and/or EXPERIENCE: BS in a related engineering discipline; and 1 – 5 years of related experience and/or training; or MS in a related engineering discipline and 1 – 3 years of related experience and/or training; or equivalent combination of education and experience. Experience in the medical device industry would be an asset. Certification and/or license in specific discipline would be an asset. Certified Quality Engineer would be an asset.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES: include the following. Other duties may be assigned.

  • Responsible for developing, applying, revising and maintaining quality standards for processing materials/products into partially or finished products.
  • Designs and implements methods and/or procedures for inspecting, testing and evaluating the precision and accuracy of products and/or production equipment.
  • Participates in engineering efforts to optimize medical component processing for Lean manufacturing
  • Supports process optimization and yield improvement goals
  • Analyzes reports and returned products and recommends corrective action.
  • Prepares documentation for inspection/testing procedures.
  • Fully competent engineer in all conventional aspects of the subject matter, functional area, and assignments.
  • Plans and conducts work requiring judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures, and criteria.
  • Devises new approaches to problems encountered.
  • Independently performs most assignments with instructions as to the general results expected.
  • Receives technical guidance on unusual or complex problems and supervisory approval on proposed plans for projects.
  • Plans, schedules, conducts, and coordinates detailed phases of engineering work in part of a major project or in a total project of moderate scope.
  • Performs work which involves conventional engineering practice but may include a variety of complex features such as conflicting design requirements, unsuitability of conventional materials, and difficult coordination requirements.
  • Work requires a broad knowledge of precedents in the specialty area and a good knowledge of principles and practices of relates specialties.
  • Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance. Responsible for the purchase or design of equipment that meets health, safety and environmental standards set by the company.
  • Responsible for pre-validation assessments to ensure the safe and environmentally sound start-up of new processes.
  • May technically supervise or coordinate the work of engineers, draftspersons, technicians, and others who assist in specific assignments.
  • Practices company safety, quality policies and procedures, actively requires conformance.
  • Responding to complaints from customers and investigating the root cause.
  • Knowledge of statistics and minitab is a must.

 


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