Quality Control Engineer - St. Jude Medical (Plano, TX)
The QC Engineer is responsible for every aspect of the control plans - quality inspection - and test plans. They will develop and inititate methods for process controls, inspection, and testing, and will devise sampling procedures, and develop forms and instructions for recording, evaluating, and reporting quality data. They will also take responsibility for training employees who are engaged in measuring, testing, and tabulating quality data.
Major, On-Going Responsibilities:
• Creation, oversight and/or maintenance of control plans including SPC, inspection and test plans, test method validations and other activities related to quality controls.
• Technical support for the quality control function.
• Participate in cross functional design controls activities as they relate or input into inspections and tests.
• Member of the material review board for non conforming material.
• Member of core team for product performance reviews to assess product quality.
• Support operations in sustaining and continuous improvement activities.
• Owner of quality control metrics such as yields, non conformance trending and other quality measures to support management reviews, product reviews, trend reviews, etc.
• Participate in process and design FMEAs.
• Trains quality control inspectors on inspection and test plans and methods.
Experience & Training:
• Bachelors degree in Electrical or Mechanical Engineering
• Knowledge of regulatory standards and requirements such as FDA 21 CFR Quality Systems Regulation, ISO13485, European Active Implantable Medical Device Directive (AIMDD), European Medical Device Directive
• Three to five years of experience in a regulated industry.
• Knowledge and experience in Metrology, Risk Management tools such and design and process FMEAs, and sampling plans.
• Knowledge of Six Sigma methodologies; CQT/CQE Certification desired.