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Quality Control Engineer - Medical Device

Company: Plastikon Industries Inc
Location: Hayward
Posted on: November 23, 2022

Job Description:

ABOUT PLASTIKONOver 30 years ago, Plastikon was established with the mission to be recognized as a world-leading plastic and contract manufacturer. Today, Plastikon continues to provide award-winning services to and plays an "essential part" in many of the world's most successful companies in their respective industries including medical, automotive and electronics. Harnessing state-of-the-art technology and dedicated employees, Plastikon has built a global reputation of exceeding customers' expectations. Our core values are simple: deliver on our commitment to provide the highest quality and value with corporate and social responsibility. In our many years as a Toyota Select Supplier, we have learned and applied the true principles of lean manufacturing, which has enabled us to control and successful growth. Our certified minority status provides another benefit to our valued customers to satisfy minority content initiatives.
Quality Control - Medical Device
Quality Control Engineer is responsible to provide and direct activities with development, application, technical support and maintenance of quality standards for all value-adding industrial processes, materials, or products. Position requires an independent thinker who has extensive analytical capabilities with respect to root cause identification, correction and prevention of issues.

  • Acquires information from customers and suppliers and communicates it internally to ensure that customer specifications and expectations are met or exceed
  • Develops and initiates standards and methods for inspection, testing and evaluation
  • Provides technical support to manufacturing functions, product and inspection issues
  • Interfaces with production, tooling and engineering to determine root cause of quality issues, action plan for correction and implementation
  • Develops and implements methods and appropriate use of SPC
  • Writes, revises and verifies quality standards and procedures for inspection
  • Identifies differences between established standards and user applications and suggests modifications to conform to standards and cGMP.
  • Monitors program performance after implementation to prevent recurrence of program operation problems and ensure efficiency of operations
  • Devises sampling procedures and designs and develops forms and instruction for recording, evaluating, and reporting quality and reliability data
  • Supports various functions in implementation of processes/systems to meet various ISO requirements: ISO 9001 and ISO 13485
  • Participates in cross functional opportunities to develop DFMEA's, PFMEA's and control plans
  • Ensures identified controls are implemented within production and quality functions
  • Facilitates corrective action and validate effectiveness of implementation
  • Participates as a member of task forces to implement projects supporting production and training
  • Compiles and writes training material and conducts training sessions on quality control activities
  • Designs and facilitates process capability, reproduce ability and engineering change to products REQUIREMENTS:
    • Bachelor's degree in Industrial, Mechanical, Electrical, or Manufacturing Engineering
    • 3+ years' experience in a GMP (medical devices or healthcare) manufacturing environment.
    • Ability to work flexible hours including weekends to support production
    • Ability to work in a fast-paced and deadline-driven environment
    • Proficient in SmartSheet and Microsoft Office tools: Outlook, Excel, Word and PowerPoint.
    • Knowledge of production/engineering of injection molded plastic, statistical process control techniques and application, and design failure analysis
    • Familiar with blueprints
    • Experience and knowledge of ISO standards
    • Working knowledge of surface plate calibration techniques, various inspection tool gauges, optical CMM, electronic test equipment
    • Knowledge of mathematical functions is essential

Keywords: Plastikon Industries Inc, Hayward , Quality Control Engineer - Medical Device, Engineering , Hayward, California

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