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Product Quality Assurance Specialist

vor 2 Monaten


Estenfeld, Bayern, Deutschland Clario Vollzeit
About the Role

We are seeking a highly skilled Product Quality Engineer to join our team at Clario. As a Product Quality Engineer, you will play a critical role in ensuring the quality and compliance of our Respiratory medical device offerings.

Key Responsibilities
  • Manage technical files and provide quality management support for design controls and regulatory requirements.
  • Participate in design control or study teams to provide input on necessary regulatory and quality requirements.
  • Creation and maintenance of technical files for responsible products.
  • Supervision and direction of quality assurance activities of all test departments.
  • Decision upon quality related measures before shipment of products.
  • Participate in Internal and external Quality Projects in R&D and Production to assure fulfilment of Quality and Regulatory requirements.
Requirements
  • Technical education (Master/Bachelor degree or equivalent) with preferred approximately 2 years' working experience.
  • Working experience in quality assurance department or design control projects preferred.
  • Basic knowledge of 21CFR Part 11, 21 CFR 820, ISO 9001/13485, ICH E6 and/or other applicable regulatory standards.
  • Experience managing CAPAs and complaints.
  • Excellent skills in analysing issues and processes.
  • Team oriented with excellent communication and organizational skills.
  • MS Office applications.
  • German and English fluent.
About Clario

At Clario, we put people first, always. We are united and driven by patients, committed to making a difference, and we are always looking for the best talent to help us transform lives.