Medical Devices QA Lead 3370

15-10-2019 braine-l'alleud
company profile

Our client is a global biopharmaceutical company focusing on creating value for people living with neurology and immunology conditions.

job description

Are you a Medical Devices QA Lead with ideally 5 years of relevant experience ?

Don't hesitate to contact me : megane.libert@cx.ausy.be

As a Medical Devices QA Lead :

Design and development management 

  • You will provide expert advice
  • You will support for technical operational QA and general QA 
  • You will oversee design and development activities 
  • You will review and approve protocols for validation studies, stability studies,... 
  • You will ensure risk assessments are performed at appropriate stages of development 
  • You will ensure deliverable are issued in accordance with the D&D plan 
  • You will facilitate investigations and resolution of issues relating to deviation and change management 
  • You will review and approve deviations during D&D activities
  • You will lead critical investigations 
  • You will track CAPA events and closure 
  • You will oversee change controls
  • You will ensure application of ISO, MDR and GMP requirements where applicable 
  • You will review and approve submissions and response
  • You will review and approve relevant sections of the device technical documentation file
  • You will release clinical trial medical devices
  • You will ensure design history file is in place
  • You will performing focused assessments 
  • You will prepare quality agreement 

General QM

  • You will maintain quality system elements associated with the ISO and GMP activities in a compliant manner
  • You will support projects related to quality system improvement
  • You will maintain key performance indicators 
  • You will maintain GMP compliance and inspection readiness 
  • You will support medical devices related inspections 
  • You will support management review process
  • You will support design reviews

your contribution

  • Minimum of 5 years working in a quality management position 
  • Practical understanding of ISO13485, MDR, ISO14972 and 21CFR820
  • Knowledge of pharmaceutical and medical devices regulations together with quality principles and techniques 
  • Be proactive, confident and enthusiastic 
  • Good communication skills 
  • Root cause analysis and risk management/assessment skills will be a distinct advantage 

what do we offer?

We offer an attractive salary with extra-legal advantages :

  • Group insurance
  • Hospitalisation insurance
  • Meal vouchers of 7 euros gross per working day
  • Reimbursement km or company car
  • Monthly allowance (50 euros net per month)
  • A 13th month
  • Training
  • Etc

A rate as freelance is also possible !

summary
function
quality and environment specialist (m/f)
employment type
full time, freelance
contract type
long term contracts
reference
CXRSP-84457
your Randstad contact
Libert Mégane
megane.libert@cx.ausy.be 02 255 16 90
02 255 16 90