Job Description

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.

Contribute to maintain Quality Management System (QMS) compliance to ensure compliance with national and international medical device regulations. Collaborate in the identification, implementation and support of automated tools to support quality management processes.

Zimmer Biomet est un leader mondial dans le secteur des dispositifs m\xc3\xa9dicaux sp\xc3\xa9cialis\xc3\xa9s en soins musculosquelettiques. \xc3\x80 Montr\xc3\xa9al, Zimmer CAS repr\xc3\xa9sente la division de haute technologie de la compagnie.

Sommaire

Contribuer au maintien de la conformit\xc3\xa9 du Syst\xc3\xa8me de gestion de la qualit\xc3\xa9 (SMQ) afin d\xe2\x80\x99assurer la conformit\xc3\xa9 aux r\xc3\xa9glementations nationales et internationales sur les dispositifs m\xc3\xa9dicaux. Collaborer \xc3\xa0 l\'identification, la mise en \xc5\x93uvre et le soutien d\'outils automatis\xc3\xa9s pour soutenir les processus de gestion de la qualit\xc3\xa9.

Principal Duties and Responsibilities

• Contribute to maintain QMS compliance with FDA QSR (Quality System Regulation) to ISO 13485: 2016, MDSAP country requirements, as well as incorporating all applicable global medical device regulatory requirements.
• Work closely with design, quality, manufacturing and other departments to ensure QMS requirements are effectively established and maintained with a proactive and preventative risk-based approach.
• Periodically report on quality system performance.
• Participate in the preparation of internal, third party or external certification audits to demonstrate compliance with GMP, ISO and EU MDR, QSR, Health Canada regulations, and other countries if applicable.
• Ensure the relevance, adequacy and effectiveness of the QMS and assess opportunities for improvement.
• Support the conduct of root cause investigations, implementation of corrective and preventive actions, and adherence to established timelines.
• Manage projects related to the introduction and support of automated quality systems.
• Ensure compliance of automated quality systems with all applicable regulations/standards and internal procedures, including validation.
• Foster a culture of quality and compliance mindset through training, mentoring and visual management practices.
• Coordinate the archiving of QMS records and procedural change requests to demonstrate compliance with FDA, ISO, and EU Medical Device Directive regulations.
• Participate in the implementation of quality improvement projects.

R\xc3\xb4le et responsabilit\xc3\xa9s

• Contribuer au maintien de la conformit\xc3\xa9 du SMQ au FDA QSR (Quality System Regulation) \xc3\xa0 la norme ISO 13485 : 2016, aux exigences des pays du MDSAP, ainsi qu\xe2\x80\x99\xc3\xa0 l\'int\xc3\xa9gration de toutes les exigences r\xc3\xa9glementaires mondiales applicables en mati\xc3\xa8re de dispositifs m\xc3\xa9dicaux.
• Travailler en \xc3\xa9troite collaboration avec les \xc3\xa9quipes de conception, de qualit\xc3\xa9, de fabrication et autres d\xc3\xa9partements afin d\xe2\x80\x99assurer que les exigences du SMQ sont efficacement \xc3\xa9tablies et maintenues, avec une approche proactive et pr\xc3\xa9ventive bas\xc3\xa9e sur les risques.
• Rendre compte p\xc3\xa9riodiquement des performances du syst\xc3\xa8me qualit\xc3\xa9.
• Participer \xc3\xa0 la pr\xc3\xa9paration des audits de certification internes, tiers ou externes pour d\xc3\xa9montrer la conformit\xc3\xa9 aux r\xc3\xa9glementations GMP, ISO et EU MDR, QSR, R\xc3\xa8glements de Sant\xc3\xa9 Canada, et d\xe2\x80\x99autres pays, le cas \xc3\xa9ch\xc3\xa9ant.
• Assurer la pertinence, l\'ad\xc3\xa9quation et l\'efficacit\xc3\xa9 du SMQ et \xc3\xa9valuer les opportunit\xc3\xa9s d\'am\xc3\xa9lioration.
• Soutenir la conduite des enqu\xc3\xaates de causes racines, la mise en place des actions correctives et pr\xc3\xa9ventives, et le respect des d\xc3\xa9lais \xc3\xa9tablis.
• G\xc3\xa9rer les projets li\xc3\xa9s \xc3\xa0 l\'introduction et au soutien de syst\xc3\xa8mes de qualit\xc3\xa9 automatis\xc3\xa9s.
• Assurer la conformit\xc3\xa9 des syst\xc3\xa8mes de qualit\xc3\xa9 automatis\xc3\xa9s \xc3\xa0 toutes r\xc3\xa9glementations/normes applicables et aux proc\xc3\xa9dures internes y compris la validation.
• Favoriser une culture de qualit\xc3\xa9 et un \xc3\xa9tat d\'esprit de conformit\xc3\xa9 par le biais de pratiques de formation, de mentorat et de gestion visuelle.
• Coordonner l\'archivage des enregistrements du SMQ et des demandes de changement aux proc\xc3\xa9dures pour d\xc3\xa9montrer la conformit\xc3\xa9 aux r\xc3\xa9glementations FDA, ISO et la directive europ\xc3\xa9enne sur les dispositifs m\xc3\xa9dicaux.
• Participer \xc3\xa0 la mise en \xc5\x93uvre de projets d\'am\xc3\xa9lioration de la qualit\xc3\xa9.

Expected Areas of Competence

• In-depth knowledge of quality system regulations and associated regulations and standards.
• Hands-on experience with quality systems and processes.
• In-depth knowledge of electronic quality management systems PLM (Product Life Cycle Management) and ERP systems.
• Excellent oral and written skills in French and English required.

Comp\xc3\xa9tences et habilet\xc3\xa9s

• Connaissance approfondie de la r\xc3\xa9glementation de syst\xc3\xa8me qualit\xc3\xa9 et des r\xc3\xa9glementations et normes associ\xc3\xa9es.
• Poss\xc3\xa9der une exp\xc3\xa9rience pratique de syst\xc3\xa8mes et de processus de qualit\xc3\xa9.
• Connaissance approfondie des syst\xc3\xa8mes \xc3\xa9lectroniques de gestion de la qualit\xc3\xa9 PLM (Product Life Cycle Management) et de syst\xc3\xa8mes ERP.
• Maitrise du fran\xc3\xa7ais et de l\xe2\x80\x99anglais, tant \xc3\xa0 l\xe2\x80\x99oral qu\xe2\x80\x99\xc3\xa0 l\xe2\x80\x99\xc3\xa9crit.

Education/Experience Requirements

• Bachelor\'s degree in Engineering or Computer Science, or Bachelor\'s degree in another discipline with related certifications (e.g. CMM, CQE).
• 3 to 5 years of experience in a quality engineering or regulatory compliance role.

Exigences en mati\xc3\xa8re de formation et d\xe2\x80\x99exp\xc3\xa9rience

• Baccalaur\xc3\xa9at en g\xc3\xa9nie ou en informatique, ou baccalaur\xc3\xa9at dans une autre discipline avec certifications connexes (ex : CMM, CQE).
• Exp\xc3\xa9rience de 3 \xc3\xa0 5 ann\xc3\xa9es dans un r\xc3\xb4le d\'ing\xc3\xa9nierie de la qualit\xc3\xa9 ou de conformit\xc3\xa9 r\xc3\xa9glementaire.

Travel Requirements

• Up to 10%.
• A current passport is required.

Exigences de voyage

• Jusqu\'\xc3\xa0 10%.
• Un passeport \xc3\xa0 jour est requis.

Additional Information

At Zimmer Biomet, we believe in The Power of Us, which means that we are stronger together. We are committed to creating an environment where every team member feels included, respected, empowered, and celebrated.

As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. This is why we offer you a competitive rewards package that includes medical, dental, vision, life and disability insurance, wellness incentives, employee assistance programs as well as paid time off for vacation and holidays.

EOE/M/F/Vet/Disability

En joignant l\xe2\x80\x99une de nos \xc3\xa9quipes, vous participerez au d\xc3\xa9veloppement de solutions innovantes qui soutiennent les chirurgiens orthop\xc3\xa9diques et cliniciens dans le soulagement de la douleur de leurs patients, et contribuerez ainsi \xc3\xa0 am\xc3\xa9liorer la qualit\xc3\xa9 de vie de milliers de personnes \xc3\xa0 travers le monde.

Pour mettre en action les valeurs qui nous motivent, nous pensons qu\xe2\x80\x99il est n\xc3\xa9cessaire de prendre soin de notre communaut\xc3\xa9 et de notre environnement. Parall\xc3\xa8lement \xc3\xa0 vos d\xc3\xa9fis professionnels, vous pourrez vous impliquer dans l\xe2\x80\x99une de nos initiatives sociales, caritatives ou environnementales.

Zimmer Biomet encourage les femmes, les personnes issues de minorit\xc3\xa9s visibles, autochtones ou en situation de handicap \xc3\xa0 soumettre leur candidature.

D\xc3\xa9couvrez les produits r\xc3\xa9cemment d\xc3\xa9velopp\xc3\xa9s par nos \xc3\xa9quipes !

Seules les personnes retenues pour une entrevue seront contact\xc3\xa9es.

Zimmer Biomet