Informacje o stanowisku

As an NPI Quality Engineer, you will be responsible for pre-production projects quality planning for assigned projects based on valid SOPs and assuring that the applicable documentation is followed according to agreed schedules. You will care of pre-production projects documentation (quality, validation, risk management, change management, internal- and external deviations) creation, reviewing, approving, and maintaining during the NPI project life cycle; risk management for pre-production projects and support NPI project team members from quality, regulatory, cGMP point of view. Moreover, you will ensure compliance of the implemented programs/processes with the client’s requirements and legal requirements as well.

Our Team

The NPI Quality Engineer position is a part of our Quality Control Team, where you will directly report to the NPI Quality Manager. As an NPI 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

• Ensure that all project related documents are created and well managed according to the regulations, customer specifications and internal quality standards
• Assisting the development of essential QMS deliverables/Advanced Product Quality Planning (APQP)
• Participating in quality improvement initiatives and projects
• Perform quality reviews and internal audits
• Review and approve change requests
• Manage the qualification of processes performed by suppliers; improve process for supplier data submission to reduce internal inspections
• Facilitate communication between engineering, manufacturing, and quality functions
• Communication liaison between the customer and manufacturing facility during the project phase
• UD decision in SAP for trial runs
• Statistical Process Control (SPC) during the project phase
• Participating in continuous improvement processes
• Promoting and applying in practice PBM rules
• Segregating wastes systematically, minimizing the use of materials
• Compliance with the health, safety and fire regulation, procedures, and instructions
• Compliance with the requirements of the systems: Quality, Occupational Health and Safety, and Environmental Management

Who You Are (Basic Qualifications)

• University degree in Quality Management
• Proven experience within a similar position in a manufacturing company
• Knowledge of quality management systems in accordance with ISO 9001 and 13485, FDA, GMP
• Demonstrated good communication, teamwork, and organizational skills
• Striving for continuous development
• Problem-solving and statistical process control skills
• Can work independently
• Good knowledge of MS Office application (Excel, Outlook)

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 ISO 14971 medical device risk analysis and quality tools
• Knowledge of Lean manufacturing for production, Six Sigma

What We Offer

• Dynamic role, supporting high end manufacturing
• Private medical care
• Life insurance
• Sports card
• Company social benefits fund
• Team-building events
• Internal and external training
• 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

Siemianowice Śląskie - Oferty pracy w okolicznych lokalizacjach