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