Your JobAs a Quality Engineer, you will be responsible for production support for the product manufacturing process (injection molding, assembly, maintaining environmental conditions), ensure compliance of the implemented programs/processes with the client's requirements and legal requirements as well and participate in the processes of implementing and maintaining the Quality Management System in Phillips-Medisize Poland. Our Team The Quality Engineer position is a part of our Quality Engineering Team, where you will directly report to the Quality Engineering Supervisor. As a Quality Engineer, you will have the opportunity to work for our new greenfield plant in Siemianowice Śląskie and collaborate with various internal and external stakeholders, including those in our international environment. What You Will Do
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 writing 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
Who You Are (Basic Qualifications)
University degree, preferable in Quality Management
Proven experience within a similar position in a manufacturing company
Knowledge of quality management systems in accordance with ISO 9001 and 13845, FDA, GMP
Knowledge of ISO 14971 medical device risk analysis and quality tools
Demonstrated good communication, teamwork, and organizational skills
Striving for continuous development
Problem-solving and statistical process control skills
Independence
Decision-making skills
Fluent English language skills
Good knowledge of MS Office application (Excel, Outlook) and SAP proficiency
What Will Put You Ahead
Postgraduate studies in Quality Management
Experience in Quality Department and GMP environment
Possess auditor competence in quality systems (ISO 9001, 13485) and GMP
Knowledge of Lean manufacturing for production, Six Sigma
Polish language skills
At Koch companies, we are entrepreneurs. This means we openly challenge the status quo, find new ways to create value and get rewarded for our individual contributions. Any compensation range provided for a role is an estimate determined by available market data. The actual amount may be higher or lower than the range provided considering each candidate's knowledge, skills, abilities, and geographic location. If you have questions, please speak to your recruiter about the flexibility and detail of our compensation philosophy. What We Offer
Interesting job in the area of manufacturing
Professional development opportunities
Private medical care
Life insurance
Sports card
Meal subsides
Company social benefits fund
Team-building events
Internal and external trainings
Working in a Principle Based Management environment where we promote honesty and respect, prefer independent employees with initiative rather than micromanagement, openly share knowledge and expect employees to be willing to learn
Who We Are As a Molex company, Phillips-Medisize mobilizes and deploys specialized capabilities and services across highly regulated industries, including health care, regulated consumer, automotive and defense. We design, develop and create innovative and life-changing medical technologies for millions of people around the globe. At Koch, employees are empowered to do what they do best to make life better. Learn how our business philosophy helps employees unleash their potential while creating value for themselves and the company. Additionally, everyone has individual work and personal needs. We seek to enable the best work environment that helps you and the business work together to produce superior results. #LI-MD2 #LI-ONSITE