Quality Assurance Specialist

Quality Assurance Specialist

Quality Assurance Specialist

 

JOB SUMMARY

Do you have a keen interest in helping to drive an efficient product release cycle?

Zephyr is a small and established medical device company, embarking on an exciting path of rapid growth. The QA Specialist will maintain heavily detailed processes surrounding inventory quality, sub assemblies. The successful individual will allow us to scale production and support of our product through agile development in a highly regulated environment. Opportunities for growth include moving into QA Specialist II and III roles.

Reporting directly to the Manager of Quality Management, you are responsible for helping ensure an effective and agile Quality Management System.

The QA Specialist will:

  • Conduct quality assurance releases on production inventory
  • Conduct Incoming Inspections on raw materials and outsourced product
  • Complete NCR’s (Non Conformance Reports) for production
  • Participate in Conducting root cause investigations and production nonconforming product, as directed by the QA Manager
  • Participate in Conducting corrective action investigations, where requested by the QA Manager.
  • Be responsible for ensuring the calibration of equipment is maintained

 

YOU ARE

  • Detail-oriented
  • Technically minded and interested in actively engaging with Operations
  • Able to thrive in a demanding role to meet deadlines
  • Flexible, independent and of high integrity
  • Comfortable in roles required heavy audit controls and paperwork
  • Positive, energetic and ready to be part of the Zephyr team

 

REQUIRED EDUCATION, SKILLS AND QUALIFICATIONS

You Have

  • A diploma in electronics, electronics engineering or related field;

Good to Have

  • Experience in a manufacturing environment
  • Experience in a Quality Control role
  • Experience with a QMS (Quality Management System)
  • ISO experience is an asset

 

ABOUT ZEPHYR SLEEP TECHNOLOGIES

Company Profile

Zephyr Sleep Technologies (“ZST” or the “Company”) designs, develops and manufactures medical devices for diagnosis and treatment of sleep disordered breathing. Zephyr has launched its second generation product, the MATRx Plus, designed to fulfill the needs of a significant and expanding market in the US. The MATRx Plus is a tablet-based and cloud-connected medical device designed to be used at the patient’s home and is currently cleared by Health Canada for sale in Canada and by the US Food and Drug Administration (FDA) for sale in the US. The MATRx Plus medical device is used to complete a two-night home study which determines: i) If a simple oral appliance is capable of treating obstructive sleep apnea (“OSA”; and, ii) a therapeutic position for the mandible. This information allows a dentist to custom make an oral appliance for an OSA patient.

Zephyr Sleep Technologies was founded in 2010 principally by Paul Cataford (CEO), John Remmers (Chief Medical Officer) and Sabina Bruehlmann (Director – Technology) and was spun out of the University of Calgary. Zephyr is a private company headquartered in Calgary Alberta with 36 employees. The intent is to grow the team to 55 by the end of 2019 Since inception, the Company has raised over $17 million – $6.7 million from investors and over $10 million from non-dilutive sources (government & strategic partners).

 

Partnership with DENTSPLY SIRONA (“D/S”)

On June 30, 2017 ZST closed a strategic investment with Dentsply Sirona (“D/S”), the largest dental technology company in the world. In addition to the investment, D/S is also “bundling” a MATRx Plus with each of its 3D AI – cone beam CT scanners in the US.

 

Traction

The MATRx is installed in 200 sleep labs and clinics in NA and over 12,000 tests have been completed since 2013. MATRx users include Kaiser Permenante in northern CA. The MATRx Plus has cleared Health Canada since the beginning of the year and is installed in close to 50 sites so far in Canada. The Company is now cleared by the FDA to sell the MATRx Plus in the US and has backlog of over $1 million. The plan is to be in 3,000-5,000 dentist offices by the end of 2020 bringing in annual revenues in excess of $35 million.

 

Our Mission

Keep it Simple

 

Our Why

To help people live healthy and productive lives by sleeping better

 

Our How

  • Do it right
  • Find a way
  • Work as a team
  • Continually improve
  • Be agile – work fast, smart and hard

APPLY

If you would like to be a part of the Zephyr Sleep Technologies Team and you are interested in this exciting career opportunity, please send your resume to info@zephyrsleep.com. Please include “Quality Assurance Specialist” and your name in the subject line. The position will remain open until it is filled. We thank all applicants for their interest; however only candidates selected for an interview will be contacted.

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