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Senior Manufacturing Quality Assurance Specialist

vor 2 Monaten


Munich, Bayern, Deutschland Beckman Coulter Diagnostics Vollzeit
About the Role

We are seeking a highly skilled Senior Manufacturing Quality Assurance Specialist to join our team at Beckman Coulter Diagnostics. As a key member of our Quality Control department, you will be responsible for ensuring the highest quality standards in our manufacturing processes.

Key Responsibilities
  • Develop and maintain inspection reports to ensure compliance with quality standards.

  • Inspect products according to specifications and quality standards, identifying and addressing any non-conformities.

  • Manage non-conformance issues through the SmartSolve system, collaborating with the team to resolve containment, disposition, investigation, and analysis phases.

  • Participate in the Andon Team, providing support for the investigation of non-conformities and ensuring timely resolution.

  • Document product inspection results and maintain accurate records.

  • Verify and approve Device History Records, ensuring compliance with regulatory requirements.

  • Coordinate with other teams to optimize inspection activities and ensure seamless operations.

  • Process and manage Oracle database materials, ensuring accurate and up-to-date information.

  • Oversee calibration management, monitoring and coordinating calibration activities with external laboratories.

Requirements
  • Technical education in a relevant field, such as quality control or quality assurance.

  • Proven professional experience in quality control and quality assurance, preferably in medical technology or a related field.

  • Proactive mindset and ability to work independently, with strong written and verbal communication skills in German and English.