Quality director (h/f)

Overview

Quality Director (H/F) role at B. Braun Group.

B. Braun est un groupe familial présent dans 64 pays, spécialisé dans la conception, la production et la commercialisation de matériel médico-chirurgical et de médicaments. Le Groupe a réalisé en 2024 un chiffre d’affaires de 9,1 milliards d’euros pour un effectif de 64 000 collaborateurs dont plus de 2 000 en France.


Responsibilities

* In cooperation with plant manager, CoES, global quality management, global regulatory affairs and the director of regulatory and pharmaceutical affairs, ensure that all operations on site are compliant with worldwide standards.
* Accountable for the management of the quality management, regulatory affairs, quality control and sterilization for qualification and validation activities; ensure the team has the knowledge, motivation and ability to meet expectations.
* Ensure a quality system compliant with regulatory requirements and internal guidelines to support audits from customers, authorities or Notified Bodies.
* As a site management committee member, contribute to achieving the sites objectives.
* Maintain effective and transparent communication with all stakeholders; act as interface between France Quality, Global Quality, global technical teams (BTC) for sterilization activities, and the site.
* Build and maintain constructive relationships with Notified Bodies and external partners; safeguard the reputation of B. Braun with authorities.
* Define and validate the vision and strategy for site quality management, regulatory affairs and quality control.
* Develop and promote quality culture on the site; define and lead quality action plans and report progress.
* Ensure compliance of all industrial and development activities on site with regulatory requirements and internal and external standards (ISO 13485, MDR, MDD, etc.).
* Oversee the site quality system and regulatory compliance; develop and improve quality systems.
* Lead quality audits of customers, Notified Bodies and Authorities in collaboration with the Director of Regulatory and Pharmaceutical Affairs.
* Ensure the management review process is conducted in a compliant manner.
* Define and analyze quality KPIs and drive actions to achieve positive trends.
* Ensure compliance with site EHS requirements within the team.


Qualifications & Skills

* Ability to anticipate issues in a complex environment and implement appropriate solutions.
* Ability to challenge and lead change; strong leadership and communication skills.
* Pragmatic approach to integrating quality standards in a simple, effective way.
* Ability to develop and maintain relationships with peers and to engage teams and stakeholders around projects.
* Ability to work in a matrix environment.


Background

* Professional background: Senior with at least 15 years in Medical Device (MD) and Quality environments.
* Strong knowledge: QA, QC, Regulatory, Sterilization and MDR/MDD.
* English: Fluent; German: appreciated.


Reports

* Direct: approximately 50 people
* External: Subcontractors


Additional Details

* Senioritiy level: Mid-Senior level
* Employment type: Full-time
* Job function: Quality Assurance
* Industries: Medical Equipment Manufacturing


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