Are you passionate about ensuring product excellence and driving continuous improvement? We're seeking a proactive Staff Quality Engineer to join our dynamic team. In this role, you'll play a vital part in maintaining product quality, implementing process improvements, and fostering a culture of excellence.

What You'll Do:

• Collaborate closely with various business functions to assess and enhance product and process quality.
• Provide guidance and oversight on Non-Conformance (NC) and Corrective and Preventive Action (CAPA) processes, leveraging your expertise in problem-solving and root cause analysis.
• Mentor and coach the quality team and other business functions on quality-related topics and activities, serving as a subject matter expert.
• Lead and manage quality initiatives and projects at both local and global levels.
• Serve as a recognized process owner in areas of expertise, including problem-solving, risk management, lean practices, and more.
• Contribute expert input into local, global, and corporate processes, driving continuous improvement and efficiency.
• Interpret KPI trends, taking proactive action to drive improvement.
• Advocate for Human Factor practices and lead efforts in identification and mitigation.
• Participate in internal and external audits, providing insightful narratives and descriptions of expertise areas.
• Support manufacturing transfers to other facilities, leading quality activities throughout the process.
• Take on management responsibilities in the absence of senior staff, ensuring continuity and excellence in operations.

Your qualifications:

• Previous experience in a regulated environment is essential.
• Proficiency in understanding Med Device manufacturing processes, ISO 13485, and GMP standards.
• Lean/Six Sigma training is required, demonstrating your commitment to process improvement.
• Strong communication skills and keen attention to detail are crucial.
• Solid understanding of engineering and quality practices and methods.
• Willingness to work collaboratively within a multi-site team, with occasional travel.
• High-level knowledge and experience of Risk-Based and statistical techniques, including process risk assessment and statistical sampling.
• Excellent proficiency in both English and Polish, both oral and written.
• Ability to champion Quality initiatives cross-functionally, leading discussions to ensure optimal outcomes.
• Minimum of 6 years of experience in a Quality Department role.

Join Us Today:

If you're ready to make a meaningful impact in a challenging yet rewarding environment, apply now to become an integral part of our Quality team!