• Quality Engineer- Medical Device

    Job Locations US-NY-Rochester
    Posted Date 1 day ago(12/12/2018 2:12 PM)
    Job ID
    # of Openings
  • Overview

    Apply quality engineering sciences and principles to all phases of product lifecycle: planning, development, qualification, manufacturing and continuous improvement. 


    • 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 materials, products and processes.  Will also compile and write manufacturing and inspection instructions/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
    • Simultaneously fulfil responsibilities on multiple program with multiple customers


    This job description indicates the general nature and level of work, duties and responsibilities expected of the incumbent.  The incumbent may be asked to perform other duties as required.  The job description may be changed if needed as determined by the Company.



    Required Competencies, Skills and Experience

    • Experience in Plastic Injection Molding
    • Experience in medical or pharma manufacturing
    • Strong analytical skills
    • Knowledge of Project Management concepts and skills
    • Desire for achieving excellence in customer satisfaction, process and product quality and reliability
    • Strong detail-oriented written and verbal communication skills, including customer interactions
    • Proficient in Geometric Dimensioning & Tolerancing GD&T ASME Y14.5, and specification reading
    • Proficient in Design of Experiments (DOE)
    • Proficient in process failure modes and effects analysis (PFMEA)
    • Strong knowledge of and practical experience using problem solving & root cause analysis tools (e.g. 8D, 5Why, fishbone, cause and effect, etc)
    • Proficient in measurement system analysis (GR&R)
    • Proficient knowledge of and practical experience with process validation concepts, phases (IQ, OQ, PQ) and applications, including protocol development and summary reporting
    • Working knowledge of ISO-13485 and FDA cGMP
    • Application of time management tools
    • Advanced knowledge of industry statistics including proficient use of Mini-Tab or similar statistics analysis software


    Education and Job Experience Requirements

    • BS Degree in Engineering or equivalent experience
    • Completion of Paulson Training, QMS and cGMP practices are required
    • ASQ certification, preferred
    • Minimum 3 years of work experience


    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.


    The work environment and physical demands detailed above are representative of those encountered while performing the essential functions of the job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the job.



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