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Senior Quality Assurance Engineer

1 month ago

Bonita Springs, Florida, United States Tyber Medical LLC Full time
Job Title: Senior Quality Control Engineer

At Tyber Medical LLC, we are seeking a highly skilled Senior Quality Control Engineer to join our team. The successful candidate will be responsible for inspection equipment programming, inspection method guidance, fixture design, and development of new inspection techniques and equipment.

Key Responsibilities:
  • Creation and optimization of inspection programming
  • Support continuous improvement of quality control, inspection processes and procedures, including developing and maintaining effective measurement methods
  • Collaborate closely with cross-functional teams on new product launches to assist in determining inspection methods, tolerancing, and dimensioning
  • Support other QMS areas as needed, including but not limited to audit support; assist in training development; CAPA investigations, and corrective actions
  • Development of fixtures and gauging to improve accuracy and cycle times
  • Provide GD&T inspection input during product and drawing development
  • Research and recommend new inspection and automation technologies to improve accuracy, throughput, and cost reduction
  • Write and execute Measurement System Analysis (MSA) Reports
  • Responsible for programming and troubleshooting program errors on a wide variety of inspection equipment including Coordinate Measurement Machines (CMM), Keyence, Starrett and other automated inspection equipment
Requirements:
  • Experience in training and working collaboratively with cross-functional teams
  • Highly skilled in GD&T application
  • Highly skilled with inspection method applications
  • Strong knowledge of programming Keyence and PC-DMIS CMM equipment as well as SolidWorks
  • Experience with Microsoft Office Suite (primarily Word, Excel, PowerPoint, and Visio)
  • Excellent organizational, interpersonal, and verbal and written communication skills, with the ability to deliver quality outputs under minimal supervision
Education/Experience:
  • Bachelor's degree in engineering or a minimum of 10 years of relevant work experience in the FDA QSR/ISO 13485 medical device industry
  • Minimum of 5 years of relevant work experience in Quality Control
  • Strong knowledge of GMP Manufacturing and Standards and Regulations
  • Experience leading a team is preferred