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)