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QA/RA Lead

Posted On:  23-Oct-2020
Job Category:  Operations, Quality & Engineering
Job Summary

The QA/RA Lead is in charge of applying and implementing the follow-up of the TE Quality system, as far as applicable to TF, in accordance with the objectives and policies set out by TERUMO Europe. This task must be carried out by the supervision and following guidelines provided by the QS Manager.

The QA/RA Lead is in charge of handling the contacts with TE/RA in order to obtain and manage the EC declarations of conformity for all products, the ISO certifications of all factories and all of the declarations needed to meet the requests of the database of the Ministry of Health, ANSM and tender department.

The QA/RA lead supervises the complaint handling process for Terumo France.

Job Responsibilities

1. Complaints & Vigilance

  • Follow and implement safety notifications / products recalls and any other corrective or preventive actions related to complaints or products NC
  • Analyze KPIs and other trends related to customer complaints (PPR)
  • Alert TE team in the event of unfavorable complaints trends / serious patient injury
  • Inform / Train TF personnel on complaints & Regulatory Affairs
  • Contact the Ministry of Health or ANSM about post market monitoring activity and healthcare advertising
     

2. Regulatory affairs

  • Closely follow up applicable legislation for medical devices distributed to France and Monaco.
  • Be aware of future trends in European and French medical device legislation, participate in discussions and try to influence when necessary (SNITEM). Participate in RA/QA Working Group in SNITEM or other organizations.
  • Keep the Terumo organization informed on national legislation, specifically on decrees, guidance published by French Competent Authorities, and other Competent Authorities under responsibility of Terumo France. Keep the Terumo Organization informed on future trends and developments in French legislation.
  • Check local promotional material for regulatory compliance.
  • Reply to various customer requests (product related questionnaires, specific statements, etc.)
  • Preparation of mandatory statements / notification to the ANSM: declaration of activity, communication of devices (France + Monaco)
  • Submit authorization requests to the ANSM for local promotional materials
  • Support preparation and submission of national reimbursement files
     

3. Quality Management

  • Implement and maintain the quality management system in Terumo France in compliance and alignment with Terumo Europe’s QMS and potential local additional requirements.
  • Create, review and update local procedures
  • Manage the local SOP approval and distribution process through SmartDoc, follow the validity of the local SOP’s (check expiry date, revisions of TE procedures when translated in French etc.)
  • Participate in internal quality audits and quality audits performed by notified bodies or customers.
  • Analyze the quality indicators, KPI
  • Prepare and manage Quality Meeting on a regular basis
  • Communicate the Quality Policy and Objectives within TF
  • Follow the corrective and preventive actions within TF
  • Implement certification of professional practices of employees in charge of presentation, information or promotion of Medical Devices.
  • Where applicable, be involved in the implementation of new Medical Device Regulation
     

4. QA/RA Team

  • Collaborate with and inform QA/RA team members.
  • Ensure compliance: supporting aoption and implementation of SmartSolve & follow-up of KPI.
  • Demonstrate (Models) the 5 Core Values in all aspects of position responsibilities.
     

5. Other

  • Train employees on Quality and Regulatory requirements.
  • Assist HR in the training plans creation / maintenance, assist employees in training process, follow up on training gaps.
  • Follow EC documentation, product modifications, launch of new products.
  • Review translation of IFU, labels.
  • Collect the necessary information and issue statements to Recylum (ESR) / Screlec (Batriweb) organizations.
  • Manage and participate to internal audits as an auditor to support TE quality auditor team.
  • Monitor the medical devices charter.
  • Support to the Legal department on the definition of the studies implemented
  • Technical support to the Legal department on patient disputes.
Profile Description

The candidate we're looking for has the following profile:

  • Master degree, preferably biology
  • Min. 5-8 years’ experience in a QA/RA specialist role
  • Interpersonal skills and work effectively in a cross-functional team
  • Good knowledge of French & English (written and spoken). Other languages are an asset.
  • Very good communicating skills, since you'll be participating to management meetings.
  • You're based in France, and live close to the office in Guyancourt. 
Offer

Terumo Europe is a core player in the EMEA healthcare market. We are a strong actor of the Terumo Corporation (Japan), producing, distributing, marketing and selling a vast range of medical devices.
Terumo Europe EMEA headquarters and production facilities are located in Leuven (Belgium) with sales and marketing offices across the EMEA region.
Working for Terumo means contributing to society through healthcare.

You will work in our office in Guyancourt, near Paris.
We offer a competitive salary, a mobile phone and other benefits.

To find out more about Terumo Europe, check our company video

Contact Person

Bethsabee Bellinck.

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