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Quality Engineer

 

Description

Join our greenfield plant in Siemianowice Sląskie as a Quality Engineer.


Purpose of the role

  • Production support for the product manufacturing process (injection molding, assembly, maintaining environmental conditions).
  • Ensuring compliance of the implemented programs/processes with the client's requirements and legal requirements as well.
  • Participation in the processes of implementing and maintaining the Quality Management System in PMPL.

What You Will Do In Your Role

  • Using quality tools to implement improvements including: process flowcharting, Pareto analysis, correlation and regression analysis, significance tests, design of experiments, statistical process control, gauge repeatability and reproducibility, and trend analysis techniques.
  • Assisting the development of essential QMS deliverables/Advanced Product Quality Planning (APQP) including, but not limited to: complaint analysis, risk analysis, failure mode and effects analysis, CAPA, and process/equipment/software verification / validation
  • Monitoring of production processes and products for adherence to company and regulatory standards and practices.
  • Participating in quality improvement initiatives and projects.
  • Perform quality reviews and internal audits.
  • Evaluating data and writes reports to validate or indicate deviations from existing standards.
  • Reviewing and approving change requests
  • Manage the qualification of processes performed by suppliers; troubleshoot and lead corrective actions relating to supplier performance; improve process for supplier data submission to reduce internal inspections.
  • Facilitate communication between engineering, manufacturing, and quality functions
  • Responsible for being a communication liaison between the customer and manufacturing facility.
  • Product release
  • Statistical Process Control (SPC)
  • Participating in continuous improvement processes.
  • Promoting and applying in practice company culture.
  • Segregating wastes systematically, minimizing the use of materials.
  • Compliance with the health, safety and fire regulation, procedures and instructions.
  • Adherence to documentation related to Quality Management System.


The Experience You Will Bring

Requirements:

  • Experience as a quality coordinator.
  • Experience as a quality assurance specialist in a manufacturing company
  • English B2/C1
  • Quality management systems in accordance with ISO 9001 and 13845, FDA, GMP.
  • Knowledge of ISO 14971 medical device risk analysis and quality tools.
  • Problem solving skills.
  • Statistical process control skills.
  • Knowledge of SAP, Excel, Outlook.
  • Creativity.
  • Positive attitude.
  • Strong motivation to work.
  • Quick adaptation to changes.
  • Striving for continuous development.
  • Ability to work in a team.
  • Good organization of work.
  • Resistance to stress.
  • Decision-making skills.
  • Active knowledge sharing.

What Will Put You Ahead

  • Experience in Quality Department and GMP environment.
  • Possess auditor competence in quality systems (ISO 9001, 13485) and GMP.
  • Knowledge of Lean Manufacturing.

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