ZOLL Circulation, Inc.

  • Incoming Quality Inspector

    Job Locations US-CA-San Jose
    Posted Date 3 weeks ago(7/26/2018 6:02 PM)
    Job ID
    2018-1073
    # of Openings
    1
    Category
    Quality Assurance
  • Overview

    General Summary:

    Provide incoming, in-process, and final inspection/testing. Duties include first article inspections, Identifying non-conformances, and documentation review.

    Responsibilities

     

    Essential Functions:

    • Support manufacturing schedule by providing inspections of incoming  materials, in-process materials and finished devices as assigned for electromechanical as well as sterile disposable products
    • Complete First Article inspections including supporting documentation
    • Identify and record any product quality problem(s)
    • Review of device history records, and perform product release
    • Support inspection of engineering prototypes
    • Data entry experience a plus
    • Initiating and/or making suggestions to improve working processes or product (i.e.,quality, productivity, etc.);
    • Set-up and/or organize QC work stations and receiving quarantine area;
    • Reviewing and auditing of quality records and manufacturing processes including device history

    Qualifications

    Skill Requirements:

    To perform the job successfully, an individual should demonstrate the following competencies:

     

    • Problem Solving - identifies and resolves problems in a timely manner
    • Oral Communication - Listens and gets clarification; responds well to questions.
    • Written Communication - Able to read and interpret written information
    • Organizational Support - Follows policies and procedures; supports organization's goals and values
    • Adaptability - Adapts to changes in the work environment; manages competing demands; able to deal with frequent change, delays, or unexpected
    • Dependability - Follows instructions, responds to management direction; takes responsibility for own actions; keeps commitments; commits to long hours of work when necessary to reach goals; completes tasks on time
    • Initiative - Volunteers readily; asks for and offers help when needed.
    • Judgment - Exhibits sound and accurate judgment
    • Motivation - Measures self against standard of excellence.
    • Planning/Organizing - Prioritizes and plans work activities; uses time efficiently
    • Quality - Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality.
    • Quantity - Meets productivity standards; completes work in timely manner; strives to increase productivity; works
    • Safety and Security - Observes safety and security procedures; determines appropriate action beyond guidelines; reports potentially unsafe conditions; uses equipment and materials

     

    Qualifications:

    • Experience in a medical device, FDA QSR regulated industry, including SO 13485 requirements
    • Experience inspecting sterile disposable catheters, electro-mechanical assemblies,as well as printed material and labeling
    • IPC 610 or equivalent experience for PCB inspection
    • Be able to interpret the sampling plans (e.,ANSI Zl.4,C =O)
    • Experience using Excel,Word, Access
    • Experience using optical inspection systems
    • Strong communications and interpersonal skills
    • Enjoys a small company, fast paced environment
    • Ability to work independently with little supervision
    • Demonstrated proficiency utilizing metrology/inspection tools (i.e., Microscope, Caliper, Micrometer, Digital Multimeter, Hipot Tester, Optical comparator )
    • Be detailed oriented

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