Quality Engineer

US-NY-Rochester
1 week ago
Job ID
2017-1252
# of Openings
1
Category
Engineering

Overview

Provide technical expertise to plan activities concerned with the development, application and maintenance of quality standards.

Responsibilities

  • Provide necessary definition, development and deployment of the company product quality assurance strategy, addressing all phases of product development, utilizing APQP (Advance Product Quality Planning) principles, including IQ/OQ/PQ validation process.
  • Manages the planning and execution of product testing efforts, including all associated resources to meet committed delivery dates, in support of new product launch
  • Maintains product consistency through all phases of manufacturing, to include the design reviews, build phases and all quality checkpoints and testing
  • Develops and implements standards and methods for inspection, testing and evaluation of products and processes.  May also compile and write manufacturing protocols to support this activity
  • Devises sampling procedures, designs and develops forms and instructions for recording, evaluating and reporting quality and reliability data
  • Develops/implements programs to evaluate analytical testing, equipment, facilities, manufacturing processes, precision measurements, accuracy measurements and performance testing
  • May direct quality department employees on processes for measuring, testing and tabulating data
  • Will work independently and in a team environment to support the daily function of the manufacturing operation
  • Will work with cross functional teams on continuous improvement projects and new program launches to ensure manufacturing process and products are optimized and cost effective
  • Problem solving using CAPA system

Qualifications

Required Competencies, Skills and Experience

  • Experience in Plastic Injection Molding preferred
  • Experience in medical or automotive manufacturing
  • Root cause and corrective action problem solving skills a must
  • Strong analytical skills required
  • Excellent problem solving, interpersonal communication and project management skills a must
  • Must have a desire for achieving excellence in customer satisfaction, process and product quality and reliability
  • Must be extremely detail-oriented with respect to documentation and communication

Preferred Skills

  • Experience with use in Mini-Tab capability analysis preferred but not required

Education and Job Experience Requirements

  • BS Degree in Engineering
  • Completion of Paulson Training, QMS and cGMP practices are required 

Work Environment and Physical Demands

  • Regularly required to sit and use hands
  • Occasionally need to lift and/or move up to 10 pounds, with a potential of up to 25 pounds.
  • Physical hazards from moving equipment and machine parts
  • Sedentary, office environment; frequent exposure to manufacturing plant floor requiring the use of personal protective equipment (ear plugs, safety glasses, etc) and following good manufacturing practices.

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