Senior Quality Engineer

Work Flexibility: Hybrid or Onsite<p></p><p></p><p><b>What You Will Do:</b></p><p>As a Quality Engineer, you’ll be part of our team in the recently established, high-tech manufacturing facility in Skawina, supporting manufacturing and business functions to maintain and improve product and process quality.</p><p><b>In this role, you will:</b></p><ul><li><p>Collaborate with cross-functional teams to ensure product and process quality</p></li><li><p>Support and approve NCs, CAPAs, and lead root cause investigations</p></li><li><p>Drive improvements in manufacturing processes for new and existing products</p></li><li><p>Review and challenge change controls and risk assessments</p></li><li><p>Analyze quality data and lead continuous improvement initiatives</p></li><li><p>Apply Human Factors and risk management principles to processes</p></li><li><p>Support internal and external audits as a quality representative</p></li><li><p>Contribute to validation planning and execution</p></li><li><p>Lead quality activities during product and process transfers</p></li><li><p>Manage product holds and support containment actions</p></li></ul><p></p><p><b>What You Need:</b></p><ul><li><p>Bachelor’s degree in Engineering, Science, or a related field</p></li><li><p>4+ years’ experience in a quality or engineering role</p></li><li><p>Knowledge of ISO 13485, GMP, GDP, and medical device manufacturing</p></li><li><p>Strong problem-solving and root cause analysis skills</p></li><li><p>Proficiency with quality tools (e.g., CAPA, validation, sampling, process controls)</p></li><li><p>Excellent communication skills in English and Polish</p></li><li><p>Ability to work collaboratively in cross-functional, multi-site teams</p></li><li><p>Experience with product transfers and validation (preferred)</p></li></ul><p></p><p></p>Travel Percentage: 10%<p></p><p></p><p></p><p></p>