Principal Responsibilities

  • Perform Test Method Validations for all in-process monitoring, analytical laboratory tests, and final release inspection and testing
  • Participate in internal and external quality audits
  • Practical application of Corrective Actions and Preventive Actions (CAPA) system
  • Develop, execute, and analyze quality-reporting measures
  • Report to management on quality issues, trends, and losses
  • Monitor storage and distribution of components and finished goods
  • Serve as a resource to internal departments for problem identification and resolution
  • Support concurrent engineering efforts by representing Quality in design development projects
  • Design and implement methods for process control, process improvement, testing, and inspection
  • Conduct trend analysis of non-conformances and other quality indicators as needed
  • Participate in supplier selection, assessment, and monitoring program
  • Participate in quality control activities such as batch records, receiving records, environmental monitoring, and product release

Required Education and Experience

  • B.S. degree in a scientific discipline (Chemistry, Biology, Physics, Biomedical Engineering, Chemical Engineering, etc.)
  • Minimum of 3 – 5 years of Quality engineering experience in the biomedical industry, preferably in medical devices
  • Thorough understanding and application of validation principles with an emphasis on Test Method validation
  • CQE, CQA, Six Sigma Black/Green belt preferred
  • Well-versed in CFR Part 820, Part 11, ISO 13485, and ISO 14971 Standards
  • Quality engineering experience with analytical tools
  • Experience in applying statistical methods for quality improvements
  • Experience in design control and process validation, root cause analysis, and corrective and preventive action (CAPA)

Required Knowledge, Skills, and Abilities

  • Computer literacy—experience with Microsoft Outlook, Excel, PowerPoint, Word, Access, and project databases
  • Management and/or interaction with multilevel staff
  • Excellent organizational skills; organized file management
  • Strong communication skills, both written and verbal
  • Professional, assertive demeanor
  • Knowledge in supplier quality engineering and management

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