Your Job
Join us as Quality Engineer.
Our Team
You will be a part of the Quality Department with a reporting line directly to the Quality Manager. We guarantee a unique opportunity to build the best Quality Team with us, which consists of 14 employees currently.
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 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
Who You Are (Basic Qualifications)
- 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.
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.
What We Offer
- Opportunities for a professional development.
- Private medical health care.
- Life insurance.
- Sport card.
- Team building events.
- Referral program.
- Internal and external trainings.
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.
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.
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