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Quality Engineer

3 months ago

Flanders, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • Support validation process through protocol drafting, approval and execution and providing validation training and guidance
  • Chair Process Change Review Board and participate in Validation Review Board meetings
  • Participate in Design Transfer/Change Control projects as the Quality Assurance Core Team Lead
  • Lead improvement initiatives for Quality Assurance
  • Independently perform full range of standard work
  • Identify and resolve more complex problems and apply problems-solving skills to handle most situations
  • Use statistical analysis and risk management techniques
  • Provide guidance for process changes, including guidance on validation requirements
  • Lead CAPA investigations
Requirements:
  • In depth working knowledge and practical application of process validation requirements (IQ/OQ/PQ) and TMV, with ability to develop and support creation of protocols and reports
  • Proven ability to lead projects
  • In-depth knowledge of requirements related to ISO 13485 and FDA QSR
  • Strong knowledge of Risk Management and Design Controls/Design Transfer/Change Control
  • Experience with product transfers and new product development projects
  • Experience with problem solving techniques and CAPA investigations
  • Strong organizational skills and ability to prioritize
  • Experience working in medical device or regulated industry
  • Proficient with Microsoft Excel, including use of pivot tables
  • Perform statistical analysis using standard software such as Minitab
  • Ability to make decisions and communicate effectively to multiple levels
  • Bachelor's degree in science or engineering field of study
  • Certified Quality Engineer (CQE) Six Sigma Certification experience preferred
  • 5-8 years of successful experience in medical device and quality engineering, and successful demonstration of Responsibilities and Knowledge as listed above

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