Quality and Compliance Manager

-Requisition Number
AMER26701
Employment Type
Full-time
Location
Montreal, Quebec

**Job Summary**:
Zimmer Biomet is a global medical technology leader. Our team members are part of a company with a heritage of leadership, a focus on shaping the future, and a mission dedicated to alleviating pain and improving the quality of life for people around the world.

Manages the compliance of Quality Management System (QMS) including the CAPA System. Ensures Compliance Training under mínimal supervision, maintains Document Control program and Product Release function to ensure compliance to domestic and international medical device regulations. Manages the identification, implementation, and support of automated tools to support the quality management processes.

**_Sommaire_**

Zimmer Biomet est un leader mondial dans le secteur des dispositifs médicaux spécialisés en soins musculosquelettiques. À Montréal, Zimmer CAS représente la division de haute technologie de la compagnie.

Gérer la conformité du Système de gestion de la qualité (SMQ), y compris le système d’Action corrective et préventive (ACEP). Assurer la formation à la conformité sous une supervision mínimale, maintenir le programme de contrôle des documents et la fonction de libération du produit pour assurer la conformité aux réglementations nationales et internationales sur les dispositifs médicaux. Gérer l'identification, la mise en œuvre et le soutien d'outils automatisés pour soutenir les processus de gestion de la qualité.

**Principal Duties and Responsibilities**:

- Responsible for all-time compliance of QMS to ISO 13485: 2016, MDSAP countries requirements, as well as integration of all applicable global medical devices regulatory requirements.
- Works closely with Design & Manufacturing Quality and other department to ensure that QMS requirements are effectively established and maintained, with a risk-based proactive and preventive approach, and report on performance.
- Ensures readiness and preparedness to Internal, 3rd party, or external certification audits.
- Assures suitability, adequacy and effectiveness of the QMS and assess opportunities for improvement and the need for changes.
- Ensures 510(k) and other regulatory submissions review from Quality perspective.
- Pursues and monitors corrective and preventive actions for applicable processes and responsible for quality process measurement and monitoring, and for the establishment and maintenance of key process indicators, quality metrics and trending.
- Provides leadership and skills to develop a strong quality collaboration with business process owners and across the organization.
- Manages projects related to the introduction and support of automated quality systems.
- Ensures compliance of automated quality systems to the QSR, other applicable regulations/standards, and internal procedures, including but not limited to validation.
- Maintaining records of training documentation according to organizational and regulatory requirements.
- Assures all departments have effective assigned training to ensure compliance with regulatory and job skill requirements Ensuring that all applicable personnel are trained on new or revised internal procedures.
- Promotes a quality culture and compliance mindset though training, mentoring, and visual management practices.
- Coordinates the archival of Device Master Records and Device History Records to demonstrate compliance to GMP, ISO, and EU MDR regulations.
- Assists department efforts in organizing audits, both internal and external, to demonstrate compliance with GMP, ISO, and EU MDR, QSR, Health Canada regulations and other countries regulatory requirements as applicable.
- Manages Change Control program.
- Assists implementation of quality improvement projects.
- Responsable de la conformité à tout moment du SMQ à la norme ISO 13485 : 2016, des exigences des pays du MDSAP, ainsi que de l'intégration de toutes les exigences réglementaires mondiales applicables en matière de dispositifs médicaux.
- Travailler en étroite collaboration avec les équipes de conception et de qualité de fabrication et d'autres départements pour s'assurer que les exigences du SMQ sont efficacement établies et maintenues, avec une approche proactive et préventive basée sur les risques. Rendre compte des performances du système qualité.
- Assurer la préparation des audits de certification internes, tiers ou externes.
- Assurer la pertinence, l'adéquation et l'efficacité du SMQ et évaluer les opportunités d'amélioration et les besoins de changements.
- Assurer l'examen 510(k) et d'autres soumissions réglementaires du point de vue de la qualité.
- Poursuivre et surveiller les actions correctives et préventives pour les processus applicables et responsable de la mesure et de la surveillance des processus de qualité, ainsi que de l'établissement et de la maintenance d'indicateurs de processus clés, de mesures de qualité e