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Quality Management Representative Nordics

Date: Dec 31, 2020

Location: GOTEBORG, SE

Company: bioMérieux

A world leader in the field of in vitro diagnostics for over 55 years, bioMérieux conceives, develops, produces and markets diagnostics solutions (systems, reagents, software and services) intended for clinical and industrial applications, which determine the origin of a disease or a contamination to improve the health of patients and insure consumer safety.

bioMérieux is present in 44 countries and serves more than 160 countries with the support of a large network of distributors. Its corporate headquarters are located in Marcy l’Étoile, near Lyon, in France.

Joining bioMérieux is choosing to be a part of an innovative company with a long term vision, committed to the service of public health and carried out with a humanist corporate culture.

Our Company offers numerous opportunities for professional development. You want to  help save lives across the globe? Join the 12,000 employees of bioMérieux!

 

 

 

We are looking for a Quality Management Representative who will be accountable for the maintenance and compliance of the Quality Management System with applicable requirements (ISO standards, Corporate requirements, Regulatory compliance, etc.) in order to ensure that customer expectations are met.

 

This role will require supporting and supervising the process owners to ensure the implementation and continuous improvement of the QMS for bioMérieux Nordics (Sweden, Denmark, Finland, Iceland, Norway). The scope of the subsidiary system today includes commercial activities including outsourced warehousing, engineering, customer support along with customer supply and sales and marketing functions.

 

 

WHAT WILL BE YOUR RESPONSABILITIES AT BIOMERIEUX?

 

Quality/Environmental Management System Representative

  • Responsible for the implementation of the corporate quality policy. Responsible for the definition and implementation of quality objectives and relevant Key Process Indicators for the subsidiary..
  • Identifies quality training needs, defines quality training plan and ensures appropriate quality training of local staff, including Quality  Inductions
  • Accountable and responsible for document and record control, including the distribution of Corporate quality documents and the implementation of the resulting applicable requirements. Contributes to the improvement of the cluster quality system.
  • Accountable to manage and execute critical supplier audits, external audits, and  internal audits to ensure inspection readiness, with support of internal auditors. Accountable and responsible for the execution of the Management reviews and outputs, Change Management, CAPA and Supplier approval processes for the subsidiary – including assuring the continued supplier qualification.
  • Efficient support to Local Customer Service to ensure that an effective complaint handling process is in place. Accountable and responsible to manage customer satisfaction surveys as required.
  • Contribute to projects/tasks from the Northern Europe Cluster and communicate about the progress

 

Regulatory Compliance Representative

  • Accountable to monitor and report  the local regulatory environment.
  • Regulatory Affairs contact for the subsidiary
  • 049783 - RD Role Description - Vigilance Contact and Backup - Europe 
  • Be the Vigilance contact for Competent authorities (CA) in the Nordic subsidiary  and back-up for other areas as required in the Northern Europe Cluster.
  • Responsible for vigilance reporting (FSCA) to authorities, and communication with authorities, customers, third parties regarding quality.
  • Accountable for the implementation of Field Actions (FCA/FSCA/CSN).

 

WHO ARE YOU ?

 

    • Bachelor of Science Degree in organisation, quality, science or relevant area. Masters’ degree preferred.
    • Minimum 3/5 years of Quality Management, Quality control, Internal auditing  experience including QMS project management.
    • Excellent Microsoft office knowledge with documented experience.
    • Expertise using Trackwise
    • Excellent verbal and written communication skills; ability to motivate and lead projects within all levels of the organization.
    • Ability to analyze and use data to drive process improvements.
    • Experience in participation in the management of regulatory audits (i.e. ISO 9001, etc.)
    • Knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards
    • Languages : Swedish and English mandatory

 

 

 

Working at bioMérieux means being involved long term with a pioneering, visionary and constantly growing company that allows its employees to live a stimulating and inspiring experience in a fulfilling work environment

Our internal mobility policy offers numerous opportunities for each of our 12 000 employees to blossom throughout their career, while respecting each employee’s individual talents as well as their personal and professional development.

At bioMérieux, over 200 professions - both scientific and non-scientific - offer our employees the opportunity to broaden their fields of expertise and develop cross-functional careers. We provide a rewarding experience in an international company that brings together talents from diverse backgrounds, thus fostering a daily aspiration to go beyond the limits.

Helping improve public health around in the world : our mission gives purpose to every profession practiced within the company.

bioMérieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity/GINA.