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:
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Collaborate with cross-functional teams to ensure product and process quality
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Support and approve NCs, CAPAs, and lead root cause investigations
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Drive improvements in manufacturing processes for new and existing products
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Review and challenge change controls and risk assessments
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Analyze quality data and lead continuous improvement initiatives
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Apply Human Factors and risk management principles to processes
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Support internal and external audits as a quality representative
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Contribute to validation planning and execution
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Lead quality activities during product and process transfers
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Manage product holds and support containment actions
What You Need:
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Bachelor’s degree in Engineering, Science, or a related field
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4+ years’ experience in a quality or engineering role
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Knowledge of ISO 13485, GMP, GDP, and medical device manufacturing
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Strong problem-solving and root cause analysis skills
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Proficiency with quality tools (e.g., CAPA, validation, sampling, process controls)
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Excellent communication skills in English and Polish
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Ability to work collaboratively in cross-functional, multi-site teams
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Experience with product transfers and validation (preferred)
Salary information will be provided during the recruitment process. ** **
Please note this is a fixed term contract, initially for 18 months
Travel Percentage: 10%