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Quality Assurance Specialist

About us:

At Myant, we are creating the world’s first textile computing platform, integrating technology directly into the only thing we’ve been wearing our entire life – our clothing.  The sensors and actuators embedded within our apparel create your Digital Identity, which will be consumed by those who matter to you - your doctors, coaches, other IoT devices, your family members - without you consciously having to think about it.  Imagine a world where you walk into your house and the temperature automatically adjusts to your optimal body temperature, the lights adjust to your mood, or your doctor is aware of the onset of a disease before you even visit.  The line between the digital and physical world is becoming increasingly blurry, and we believe textile is the next medium to further bridge that gap.

We’re looking for people who believe in our mission to make wearable technology truly ubiquitous and convenient, so that everyone can benefit from it.  We are a cross-functional team solving big challenges at the intersection of fashion, electronics, software, and data science.

 

The Role:

The Quality Assurance Specialist position requires application of seasoned engineering knowledge in planning, conducting and leading projects. It also requires the capacity for independent accomplishment and coordination of difficult and responsible assignments. He/she is accountable for the planning and completion of process development projects, including the design and development of manufacturing processes, documentation, and equipment to successfully implement new and changed products into manufacturing.

 

Responsibilities:

  • Provide quality engineering support to engineering project teams associated with new product development projects or process improvement projects.  Review all studies, qualifications, and changes associated with the project.
  • Develop and revise quality system procedures (SOPs, WIs, etc.).
  • Develop/ write protocols and coordinate the testing for verification/validation activities, component qualification activities, IQ/OQs, and test method validations.
  • Develop and maintain risk management files and quality control plans for components, devices and processes.
  • Compile and analyze data for quarterly Management Review program.
  • Provide training and/or technical guidance to production staff as required.
  • Uses statistical analyses and interpretations for investigations, specification setting activities, and test protocols.
  • Support supplier and/or material qualification activities for all new/modified articles.
  • Support the review and timely completion of Nonconformance and CAPA reports.
  • Support the development and optimization of the Quality Management System.
  • Prepare and support internal/external audits and inspections.

 

Qualifications:

  • BS degree or higher in an engineering or scientific discipline.
  • Minimum of 3-5 years of experience in manufacturing, process validation, and quality from a medical device or pharmaceutical industry.
  • Must be able to demonstrate basic engineering/ applied science knowledge including but not limited to: math, electric circuits, materials, statistics, physics and chemistry.
  • Familiar with Quality System regulations on medical devices, ISO 9001, ISO 13485, and ISO 14971.
  • Solid experience in writing and conducting validation protocols.
  • Understanding of IEC 62304 and software validation processes is an asset.
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