Senior Quality Engineer

About Us

CloudCath is a small, fast paced, medical device startup, redefining infectious disease remote monitoring for catheter-based treatments.  

Our initial focus is end stage renal disease patients that are on peritoneal dialysis. These patients rely on implantable catheters to perform dialysis in home settings on a regular basis. Living with and managing this catheter in an outpatient setting without continuous medical supervision can result in multiple complications, including infection. Existing standard of care relies on patients’ compliance with patient dependent manual infection monitoring methods such as visual inspection of their fluids. Our system, using our device and proprietary algorithms, enables physicians to remotely detect the early signs of infection and other complications. Early complication detection allows for earlier intervention, keeping patients out of the hospital, preserving their therapy longer, and avoiding morbidities from complications.

What you do

You will take a patient-interfacing Class II medical device from clinical and technical validation, to volume scale-up and commercialization. As a Sr. Quality Engineer, you will be the quality lead for manufacturing activities including process improvement projects, validations, and product builds. You will support contract manufacturing activities and partner with suppliers to troubleshoot and find solutions to problems.

In addition, in this role, you will leverage your quality engineering knowledge in conducting supplier non-conformances, complaint and CAPA investigations in order to understand potential device failures. In coordination with manufacturing engineering, you will develop and execute testing for verification and validation activities. You will also work with cross functional teams on other quality system related activities including but not limited to supplier evaluations and risk management, and design control activities.

Who you are

You thrive in opportunities to improve and scale a company in a fast-paced startup environment with like-minded collaborators. You take a hands-on approach to overcome manufacturing scale-up challenges.  

The Senior Quality Engineer is responsible for Quality Assurance activities ranging from product development through transfer to manufacturing. This is a hands-on role where the Senior Quality Engineer will apply intensive, self-directed and diversified knowledge of engineering and quality principles and practices for medical devices. You will work independently with little to no supervision and exercise considerable discretion in determining objectives and approaches to significant organizational projects or assignments.

Minimum qualifications

  • Bachelor degree in Engineering or Life Sciences required.
  • Minimum 4 years of medical device industry experience required, will consider applicants with more senior level experience.
  • Clear understanding of QSR (21 CFR 820) / ISO Quality System (ISO 13485).
  • Experience in a full product life cycle, including definition of customer needs, development, design testing, design transfer, manufacturing scale up, distribution, service and post market analysis is critical.
  • Sound understanding of concepts and principles of Quality Assurance with respect to external suppliers, product manufacturing and product servicing is necessary.
  • Experience with Class II or Class III device manufacturing.
  • Perform, coordinate, review, approve, and/or provide guidance on:
    • Product Verification & Validation activities
    • Product specification
    • Design Control Documentation
    • Risk Management
    • Supplier Management
    • External Standards and Regulatory Audits
  • Experience with root cause analysis. 
  • Familiarity with electromechanical assemblies.
  • Experience in dynamic team environments.
  • Experience in maintaining accountability for project timelines and deliverables to management.
  • Requires the ability to travel approximately 20% of the time. 

Preferred Qualifications

  • Experience with diagnostic equipment. 
  • Experience with sterile disposable devices.
  • Practical application of statistical concepts including SPC techniques, hypothesis testing, DOE, and sampling plans.
  • Must be able to professionally present to management and interface with all departments, represent the company professionally to suppliers, and third-party auditors.