Quality Assurance Specialist

5 days ago


Flanders, New York, United States Katalyst Healthcares and Life Sciences Full time

Quality Assurance Specialist

Katalyst Healthcares and Life Sciences is seeking a Quality Assurance Specialist to support the validation process through protocol drafting, approval, and execution. The ideal candidate will provide validation training and guidance, chair the Process Change Review Board, and participate in Validation Review Board meetings.

Responsibilities:

  • Support validation process through protocol drafting, approval, and execution
  • Provide validation training and guidance
  • Chair Process Change Review Board
  • Participate in Validation Review Board meetings
  • Lead improvement initiatives for Quality Assurance
  • Independently perform full range of standard work
  • Identify and resolve more complex problems and apply problem-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
  • 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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