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.
- 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
- 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