Join our greenfield plant in Siemianowice Sląskie as a Quality Engineer.
Purpose of the role
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
- 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.
- 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.