Quality Post-Market Surveillance Specialist - Utrecht

Vacancy information

Publication date:February 12 2020
Employment type:Permanent
Sector:Medical Devices
Function Group:Quality/RA

Function Group: Quality/RA / QA Engineer

Organization

For a rapidly growing medical devices scale-up, we are looking for a (Quality) Post Market Surveillance Specialist. The organisation develops and produces innovative and life changing electronic medical devices with the goal to give people more time to enjoy life. This organisation is one that people can rely on.

Currently, the organisation experiences tremendous growth, and is expected to become a global leader in the near future. At the moment, about 100 employees work at the organisation which are talented and ambitious professionals who believe in a work hard/play hard approach.

You will be part of the regulatory team working closely with the customer care department. By being in touch with these stakeholders, you will be able to set-up and manage the complaint process perfectly.

Function

As a (Quality) Post-Market Surveillance Specialist you are the internal expert on the entire complaint process. All departments in this organisation are developing themselves and optimising their processes, also the complaint handling department. Therefore you would also be responsible for setting-up the entire process around complaint handling. This asks for a certain proactivity and experience.

Additionally, you will be responsible for the analysis of complaint data for improvement of the complaint system, and will act on the outcomes towards relevant stakeholders. You will review device history records and work closely with the quality department for Supplier Corrective Action Requests (SCARs) and Corrective and Preventive Actions (CAPAs). Also, you will keep the complaint documents updated and close complaint records. Lastly, you will stay up-to-date on relevant and/or new regulations, and will ensure that these regulations are applied in regards to Medical Device Reporting and Risk Management.

Requirements

A large dose of proactivity is asked for this role. Next to that:

  • Bachelor in Quality/Biomedical/Mechanical field
  • At least three years of experience in a similar role at Medical Devices companies with manufacturing or production environments
  • Knowledge of ISO 13485 and 21 CFR 820
  • Proven experience with complaint handling processes and setting-up/optimising this process
  • Strongly skilled in: FMEA, CAPA, Risk Management, other quality-related tools
  • European work permit
  • Fluency in English

Offer

The organisation can offer you the following:

  • Expected monthly salary range of €3,500 to €5,000 depending on your experience and expertise
  • 25 holidays and up to 13 ADV (time for time) days per year
  • Defined benefit pension scheme and disability insurance
  • 40 hours per week to be worked anytime between 07:00 to 19:00
  • Assistance for relocation and 30% ruling
  • Team lunches and events outside of working hours
  • Great and relaxing atmosphere in the office
  • Informal dress code

Application

If you are interested in this job, or in similar ones, please feel free to contact me directly.

Saskia Cepella
Consultant Quality & Clinical | Medical Devices

+31(0)6-13143973
+31(0)23-7548660
s.cepella@qtcrecruitment.com

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Contact

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