Capstan Medical, Inc.
Capstan Medical, Inc.

Quality Assurance Technician

TLDR

Inspect implantable heart valves, review Device History Records, monitor environments, and support testing and non-conformance disposition.

Description:

  • Provide support in production-line Quality inspections for implantable medical device (heart valve)
  • Provide support in execution of inspection and/or test procedures to evaluate all aspects of development of new products.
  • Provide support in review of Quality records such as Device History Records of product sub-assemblies and/or finished goods.
  • Provide support in Quality inspections of supplied medical device components and associated record keeping.
  • Assist Quality Assurance team in remedial actions to support disposition of product or component non-conformance
  • Assist in environmental monitoring processes and associated record keeping.
  • Operate specialized equipment that supports established test and/or cleaning activities.
  • Skills:

  • Ability to read manufacturing prints and identify associated specifications/characteristics related to inspection and testing to be performed
  • Ability to perform visual inspections (i.e. detect defects) using a microscope and/or magnification visual inspection system
  • Ability to use computer and general office software for data entry
  • Requirements:

  • AA degree or equivalent directly transferrable work experience
  • Minimum of 3 years of professional experience working in a Class III medical device manufacturing environment
  • Capstan Medical is developing a first-of-its-kind robotic platform for minimally invasive heart valve treatment. By integrating surgical robotics, catheter-based delivery, and next-generation implants, we aim to make complex procedures safer and less stressful for both patients and clinicians.

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