Quality Control Engineer – Healthcare

Plastikon Healthcare is looking for a Quality Control Engineer to provide and directs 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.

RESPONSIBILITIES:

  • 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

Source: Monster.com
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