Superviseur Qualité

Company Description

Our client, an international company in Medical Devices based in France is looking for their next QA Supervisor in Nancy.

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Job Description

MAIN MISSIONS:

The QA Supervisor manages a team of Quality coordinators and oversees the Quality Management System
of the company, implements the policies and procedures accordingly and maintain them over the time.
Under the responsibility of the Quality Director, you will promote and spread the QA culture within the
organization to ensure full customer satisfaction.

ROLE AND RESPONSIBILITIES:

• Management of the QA team:

o Direct management of 4 Quality Coordinators in the different Regional Units
o Monitoring: Review and approval of GCP/QMS relevant Documents like Plans, Protocols,
Reports, SOPs, Quality Incident Management, CAPA (corrective action and preventive action),
Risk Assessment
o Oversee and ensure adherence and compliance to regulatory requirements and internal
policies, procedures and standards.
o Assist management in regulatory inspections and performing internal as well as third party
audits.
o Assist management in the completion of request of information and questionnaires from
customers.

• Coordinate the Implementation of policies, procedures and trainings:
o Handle the QMS document system.
o Drive the efficient communication to all stakeholders on the Policies and Procedures of
the QMS.
o Manage the team who Train and/or organize training when relevant.
o Detect improvements opportunities to make QMS live and aligned with business needs
and practices.

• Quality incident management:
o Detect, investigate, report, manage incident issues.
o Ensure corrective and preventive actions are defined and implemented in collaboration
with managers.

• Customer audits:
o Be the point of contact of the customer before, during and after the audit.
o Ensure that the organization is focused, prepared and available during the audit.
o Guarantee that audit report and minutes are provided on time and at the right quality
standard.
o Ensure all raised issued are answered properly and in time to customer.

• Coordinate and ensure the good implementation of the process.
• Risk Assessment
• Vendor management:
o Participate in the management of suppliers of equipment, consumables or services that
impact the Group’s QMS and Good Clinical Practices:
o Collaborate in selection and evaluation activities.
o Carry out audits and qualification of supplier performance according to risk analysis

INTERFACES:

• Externally:
o Customers.
o Suppliers.
o Quality consultants.

• Internally:
o Strong link with all group process owners.
o Interface with managers of department.

PROFILE:
o Fluent in English.
o French is a plus or any foreign language.
o Graduated from a master’s in QSE.
o Significant experience in QMS and on conducting quality audits or assessments.
o Experience in management.
o First experience in a Medical, Pharmaceutical, Bio-Medical/Pharma environment.
o Knowledge of quality standards and International Medical devices regulations: ISO 9001,
ISO13485, ICH E 6 – GCP CFR21 PART 820 & part 11, Medical Device Regulation 2017/745 and
746, as well as quality methods and tools.
o Proficient in computing system.
o Autonomous, good communication skills, rigor, results oriented.
o Synthetic and analytical
o Must be able to work in a team & individual environment, interacting effectively at all levels, and
across all functions with ability to develop organizational relationship.

OBJECTIVES & KPIs:
• Incident rate
• CAPA compliance rate
• Training compliance rate
• Numbers of critical points detected during customer audits.
• Customer satisfaction survey on Audits.

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