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Efficiency through standardisation

 

Vacancy Junior QA Manager

MedEnvision the company

MedEnvision is a successful young and dynamic company selling products worldwide (Europe, US, Australia, etc). The company originates from an innovate idea coming from a surgeon who wanted to improve his efficiency in the OR. A coherent group of people, with an academic and industrial background, put their heads together in 2011 to investigate the idea and it’s feasibilities. Shortly afterwards, MedEnvision was founded and the ISO13485 certificate was obtained.  After patent examination and subsequent patent application in 2012, the first prototype was clinically tested. Currently, MedEnvision launches three product lines, which are all CE marked and FDA listed.

For our offices in Aarschot we’re looking for a motivated colleague to further support our growth.

Function

  • Manage and execute the QA activities supported by our legal officer
  • Manage and execute all activities related the company’s Quality Management Systems
  • Manage and execute all technical files regarding current and new products
  • Manage Product Documentation and Product labeling review and approval
  • Manage sub-contracting Quality Agreement review and approval
  • Manage Quality Assurance activities related to Incoming Inspection
  • Manage customer complaints and CAPA management
  • Manage the supplier’s production QC and regulatory compliance improvement programs

Competences

  • Bachelor or Master degree in a relevant field
  • Knowledge of and experience regarding technical testing process of medical devices
  • Knowledge of and experience regarding Production Quality & Process Validation
  • Knowledge of and experience regarding clinical validation and testing of medical devices
  • Proficient in the English language, both written and verbal
  • Knowledge of and experience regarding ISO13485 and MDR are a plus
  • MS Office

Personality

  • Autonomous character
  • SME minded

MedEnvision offers

You’ll work in an innovation driven organization with an entrepreneurial and transparent culture. MedEnvision offers you an attractive salary and the opportunity to take the lead in our QA activities.

Contact

info@medenvision.com

Vacature Junior QA 2019_01

AAOS 2019 Las Vegas

The MedEnvision team is looking forward to welcome you at our booth 6227

MedEnvision @ Efort Barcelona

MedEnvision will be present at the 2018 Efort conference in Barcelona. We invite you to visit us at our booth A6.

Together with DePuy Synthes we are glad to even better support the France Orthopaedic surgeons

France. We are proud to announce that Medenvision has signed a distribution agreement with DepuySynthes France, division of Johnson & Johnson Medical SAS. Depuy Synthes is a leading manufacturer of innovative medical devices & solutions. Together with the people from DePuy Synthes in France, Medenvision will assist surgeons in optimizing efficiency and productivity in their OR by using the Gripper and EsySuit.

MedEnvision @ 2018 AAOS New Orleans

MedEnvision is proud to welcome you again at our booth in New Orleans from the 7th until the 9th of March

Looking forward to meet you all in New Orleans at our booth 4023