PlusOne

Quality Manager - Medical Devices - Mont-Saint-Guibert

Company

Located in Laguna Hills, California, USA, and Mont St-Guibert, Belgium, our client is a thriving, fast-paced development company with an entrepreneurial environment.

They are prepared to revolutionize the management of diabetes. They are developing the world’s first opto-enzymatic Continuous Glucose Monitor (CGM), a low-cost sensor in the form of a disposable patch, that combines an enzymatic chemical reaction with laser light to measure blood-glucose. This CGM communicates with a smartphone or smartwatch to deliver measurements, predictions and alerts and to provide insights to diabetics to better manage their disease.

They envision a world where the effort of diabetes management does not consume the lives of people living with diabetes, as well as those who care for them: Less thinking. Less worrying. More doing. This principle is at the core of the development of their solution.

Leveraging their innovative and unique technology, the company is committed to developing and commercializing a revolutionary Continuous Glucose Monitoring solution, which will be deeply rooted in users’ individual needs, and shaped by the overall healthcare system, aiming to define a new standard of care in the management of diabetes.

To reinforce their team, we are currently looking for a Quality Manager

Role

You are looking for a professional challenge that allows you to work in a start-up environment and to act as Quality Manager?

After a Software Development experience, you have oriented your career in Quality Management? As Team Leader, you want to coach your own team in order to reach high quality standards? You want to use your leadership skills and your good communication skills in order to participate to the development of a fast-growing company?

Plus One can offer you this great challenge:

Mission

As Quality Manager, you will be responsible for leading the Quality function a performing a variety of duties to ensure the compliance of the work being performed along with the Development Team.

Your responsibilities

• Work closely with the Software Team.

• Provide QC/QA leadership to the local team.

• Collaborate in developing local quality procedures and instructions.

Practically, it means that you will be in charge of providing leadership and technical support for the quality assurance and testing functions and you will be a key contributor to cross functional process improvement and problem solving.

Profile

Experience

  • A minimum of 10 years
  • ISO 9001/13485 Quality System (Medical Device) experience (Class III Medical Device – FDA)
  • Minimum of 5 years Software Quality experience
  • Demonstrate management skill though at least 3 years of management experience
  • Must be able to work effectively and collaborate within cross functional teams
  • Must be able to effectively articulate (verbally and in writing) results and conclusions to technical and non-technical personnel

Education, Skills & Knowledge

  • Master degree in an Engineering discipline
  • Must have strong documentation skills
  • Must take initiative and have the ability to conduct hands-on work
  • Must possess the ability to handle multiple tasks with high attention to detail
  • Familiar with and comfortable functioning in a small, face paced med device start-up environment NOT a “Big Company” mind-set
  • Must be hands-on, willing to get into the trenches and get their hands dirty.
  • Creativity and flexibility is key
  • Full proficiency in English is a requirement, other languages appreciated.
  • Must have the ability to travel internationally (2 annual travels) and work at times according to the Californian Schedule with Evening Conference calls.

Offer

  • Full time with flexible schedule and homeworking possible, up to 2 days/week
  • Permanent contract (employee)
  • or long term collaboration if freelance
  • Location: Mont-Saint-Guibert (Belgium)
  • Start date: ASAP

Publication date

06.12.2019

Contact person

Gaëlle Minet

Visitors who applied for this job also applied for these jobs:
All vacancies
Plus One uses cookies to remember certain preferences and align jobs interests.