Senior Quality Assurance Engineer

11 godzin temu


Warszawa, Mazovia, Polska Chabre IT Services Sp. z.o.o Pełny etat
About the Role

We are seeking a highly skilled Senior QA Engineer to join our team at Chabre IT Services Sp. z.o.o. As a Senior QA Engineer, you will play a critical role in ensuring the quality and regulatory compliance of our medical device products.

Key Responsibilities
  • Develop and maintain quality management system procedures to support regulatory compliance
  • Monitor and analyze the effectiveness of the quality management system and implement improvements
  • Collaborate with cross-functional teams to develop and implement regulatory strategies and pathways for medical devices
  • Conduct internal audits and ensure timely follow-through on resolution of related audit findings
  • Participate in the evaluation and approval of suppliers
  • Provide quality and regulatory-related training to colleagues
Requirements
  • Working knowledge as Senior QA Engineer with experience in medical device regulatory or other regulated business
  • Proven practical experience with medical device standards such as ISO 13485, ISO 14971, IEC 62304 & IEC 62366
  • Considerable knowledge of medical device software and/or hardware development and production
  • Excellent interpersonal, written, and verbal communication skills (English)
  • Ability to represent the company during audits
  • Ability to work independently and effectively without supervision
  • Shows an organization & business awareness, including customer focus
  • Capability to solve complex problems
What We Offer
  • Competitive rate of 160.00 PLN/h + VAT
  • Remote work
  • Subsidy for peripherals in the amount of 500.00zł
  • Working tool (MacBook Pro or Lenovo Legion 5)
  • Co-financing of courses related to the position
  • Benefits: MultiSport, Medicover


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