Director Quality Assurance

CONMED Corporation; Saint-Priest; Sur place; EUR 80 000 - 120 000; Plein temps

Résumé du poste

Une entreprise de dispositifs médicaux recherche un Directeur Assurance Qualité pour superviser les systèmes de qualité conforme aux normes FDA et ISO. Ce poste exige de la gestion d'équipes et la direction de projets internationaux dans un contexte de conformité réglementaire. Vous aurez la responsabilité d'assurer l'amélioration continue des processus et de promouvoir une culture de qualité au sein de l'organisation.

Qualifications

• 10 ans d'expérience en Fabrication/Audit Qualité, 5 ans dans les dispositifs médicaux.
• Expérience de gestion de 5 ans minimum.
• Succès prouvé dans la mise en place de systèmes qualité.

Responsabilités

• Gérer l'équipe qualité et assurer la conformité avec les exigences FDA et ISO.
• Diriger des programmes internationaux pour accélérer l'enregistrement des produits.
• Superviser les audits internes et externes.

Connaissances

Connaissance des exigences QSR/ISO et mondiales

Principes d'assurance qualité

Compétences en communication écrite et orale

Passion pour la qualité et amélioration continue

Formation

Diplôme d'ingénierie ou discipline connexe

Description du poste

Director Quality Assurance

Purpose

Leads QMS system administration and enhancements at the Foot and Ankle facility in France, actively participating in global improvement initiatives. Ensures compliance with FDA Quality System Regulations, ISO 13485 standards, and other international standards and regulations for all quality system processes and procedures. Oversees Quality Assurance and Quality Engineering activities to foster a culture of continuous improvement and ensure manufacturing processes conform to documented requirements.

Leads special international projects in Quality Assurance and Regulatory Affairs to promote QMS harmonization and regulatory registration excellence.

Key Duties and Responsibilities

Management of the In2Bones Quality team – 50%

• Provides leadership in developing, implementing, and maintaining methods to ensure quality system compliance with FDA QSR and ISO 13485 requirements.
• Acts as an influential leader driving compliance within the team and across the organization.
• Sets goals and priorities for the Quality Systems group.
• Supports the CAPA process to ensure effective root cause analysis and corrective actions for nonconformances.
• Manages the departmental budget, ensuring fiscal responsibility.
• Allocates resources for training and meeting quality requirements.
• Supervises personnel in the Quality Assurance group, ensuring fair and consistent management.
• Hosts and manages government inspections and QS audits.
• Supports internal and external audit processes.

Program management of international special programs

• Leads the APAC control tower program to accelerate product registration in the region.
• Develops and maintains international metrics for quality assurance and regulatory affairs.
• Leads projects to harmonize international quality systems.

Additional duties may be added at the manager's discretion based on business needs.

JOB REQUIREMENTS

Minimum Requirements

Education

• Bachelor’s degree in Engineering or a related discipline.

Experience

• At least 10 years in Manufacturing/Quality Assurance, with 5 years in Medical Device or FDA-regulated industries.
• Minimum 5 years in a management role.
• Proven success in implementing and maintaining quality systems.

Other Attributes

• Proficient knowledge of QSR/ISO and global requirements.
• Strong understanding of quality assurance and manufacturing principles.
• Excellent written and verbal communication skills in English and French.
• Passion for quality and continuous improvement; experience leading international projects.

Preferred Requirements

• Proven track record of building and developing teams in matrix organizations.
• Ability to effectively collaborate with different business functions.
• Quality certifications such as CQM, CQE, CQA, or Lead Assessor.
• MBA or Master’s degree.