Senior Quality Engineer

Work Flexibility: Hybrid or Onsite

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%