Quality Manager

1 month ago

Montréal, Canada Bio-Rad Full time

Le gestionnaire de la qualité affecté à ce poste sera responsable de la mise en œuvre, du maintien et de l’amélioration du système de gestion de la qualité au niveau commercial et de la distribution, de la supervision de la qualité, ainsi que du développement et de la direction de la fonction d’assurance de la qualité pour Bio-Rad Canada, en veillant à ce que le système de gestion de la qualité soit efficace et réponde aux exigences des clients et des organismes de réglementation. Cette personne jouera le rôle de gestionnaire et devra faire preuve d’excellentes compétences en matière de leadership, de communication, en pensée critique et en organisation.

*****Le bilinguisme est requis - anglais et français*****

L’impact du candidat 

Maintiens et améliore le système de gestion de la qualité du site conformément à toutes les normes et réglementations applicables, ainsi qu’aux exigences de l’entreprise en matière de qualité et de réglementation. Améliore la culture de la qualité et les relations de collaboration avec les principales parties prenantes et les partenaires commerciaux. Gère la collecte, l’analyse et la communication des données relatives aux performances du système de gestion de la qualité. Approuve la correction, le confinement et la communication par rapport aux problèmes de performance de produits identifiés. Autorise les modifications de produits et de processus complexe ayant des niveaux d’impact modérés et élevés. Agis comme le représentant du système de gestion de la qualité. Gère le processus de gestion de la documentation du SMQ du site. Coordonne le programme d’audit interne du site. Agis comme le point de contact principal pour les audits et les inspections.

Ce que le candidat apporte :

 Formation : Baccalauréat en ingénierie, biologie, chimie ou dans une discipline connexe.Au moins 5 ans d’expérience pertinente, y compris une expérience de supervision, ou une combinaison équivalente de formation et d’expérience, une expérience pertinente dans l’industrie des dispositifs médicaux et des systèmes de qualité dans un environnement réglementé (BPF ou ISO 13485, exigences de Santé Canada). Aptitudes : Au moins deux ans d’expérience dans l’utilisation de systèmes ERP (planification des ressources de l’entreprise) tels que SAP ou Oracle. Expérience de l’élaboration et de la mise en œuvre de processus, de procédures et d’activités liées au système de gestion de la qualité. Compétences en communication, allocution publique, prise de décision, traitement de texte, logiciel tableur et négociation. Une certification en tant qu’auditeur principal ISO13485 est un atout. Expérience en matière d’audit (interne, externe, tierce partie). Des compétences en matière de gestion de projet, d’habileté multitâche, en management, en relations interpersonnelles et en leadership sont indispensables.

Programmes de rétributions complets  : Chez Bio-Rad, nous sommes motivés par notre mission et nous savons que nos employés le sont aussi. C’est pourquoi nous proposons un programme de rémunération globale compétitif et complet offrant valeur, qualité et inclusion tout en répondant aux divers besoins de notre personnel en constante évolution. Les offres solides de Bio-Rad servent à enrichir la santé globale, la richesse et le bien-être de nos employés et de leurs familles à travers les différentes étapes du travail et du cycle de vie d’un employé. Nous sommes fiers de proposer des options telles qu’un ensemble complet d’avantages sociaux, une assurance vie et une assurance invalidité, un régime de participation différée aux bénéfices, de vastes possibilités de formation et de développement, un programme d’aide à l’éducation, des subventions pour la remise en forme, des congés, etc.

Qui sommes-nous  : depuis 70 ans, Bio-Rad se consacre à la progression du processus de découverte et à la transformation des domaines de la science et des soins de santé. Comptant parmi les cinq premières entreprises du secteur des sciences de la vie, nous sommes un leader mondial dans le développement, la fabrication et la commercialisation d’une large gamme de produits de recherche et de diagnostic clinique de haute qualité. Nous aidons les gens partout dans le monde à vivre plus longtemps et en meilleure santé. Bio-Rad offre une expérience unique à ses employés grâce à des équipes collaboratives réparties dans le monde entier. Ici, vous êtes soutenu par les dirigeants pour construire votre carrière et vous êtes habilité à conduire des changements qui ont un impact visible.

Equité en matière d'emploi:  Bio-Rad est un employeur qui respecte l’égalité des chances en matière d’emploi et nous accueillons les candidats et candidates de toutes origines. Les anciens combattants et combattantes, les personnes handicapées, toutes les personnes, peu importe leurs race, ethnicité, genre, âge et orientation, sont encouragés à postuler.

Non-sollicitation de l’agence  : Bio-Rad n’accepte pas les CV d’agences, sauf si l’agence a été autorisée par un représentant de Bio-Rad. Veuillez ne pas soumettre de CV à moins d’être autorisé à le faire. Bio-Rad n’assume pas les frais liés aux CV non sollicités.

Alerte à la fraude : Bio-Rad a reçu des rapports d'individus se faisant passer pour des recruteurs de Bio-Rad afin d'obtenir des informations, y compris personnelles et financières, de la part de candidats. Méfiez-vous de ces faux "recruteurs" et de ces escroqueries à l'emploi. Cliquez ici pour plus d'informations sur cette escroquerie et sur la manière de l'éviter.

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This Quality Manager role will be responsible for implementing, maintaining, and improving the commecial and distribution Quality Management System, providing quality oversight, and developing and leading the Quality Assurance function for Bio-Rad Canada, ensuring that the QMS is effective and meets customer and regulatory requirements. This individual will function in a management role and must demonstrate excllent leadership, communication, critical thinking, and organizational skills.

*****Bilingualism is required – English and French*****

How You'll Make An Impact:

Sustain and improve the site Quality Management System in accordance with all applicable standards, regulations, and Company quality and regulatory requirements. Improve the quality culture and cross-collaborative relationships with key stakeholders and business partners. Manage the ongoing collection, analysis and communication of QMS performance data. Approves correction, containment and communication in response to identified product performance issues. Authorizes product and process changes with moderate to high complexity or impact. Serves as the Quality Management Representative for the Quality Management System. Managing the site QMS documentation managagement process. Coordinating the site internal audit program. Primary point of contact for audits and inspections.

What You Bring:  

Education: Bachelor’s degree in Engineering, Biology, Chemistry, or related discipline. Communication, public-speaking, decision-making, word processor, spreadsheet, and negotiation skils. Certification as an ISO13485 lead auditor a plus. Audit experience (i.e. Internal, External, 3rd party). Project management, multitasking, organizational, interpersonal, and leadership skills a must.

Required Experience: 

Minimum 5 years relevant experience including supervisory experience, or equivalent combination of education and experience, relevant medical device industry and quality systems experience in a regulated environment (GMP and/or ISO 13485, Health Canada requirements). Minimum 2 years experience working with ERP (enterprise resource planning) systems such as SAP or Oracle. Experience with the development and implemention of QMS processes, procedures, and activities. Audit experience (i.e. Internal, External, 3rd party).

Total Rewards Package: At Bio-Rad, we're empowered by our purpose and recognize that our employees are as well. That's why we offer a competitive and comprehensive Total Rewards Program that provides value, quality and inclusivity while satisfying the diverse needs of our evolving workforce. Bio-Rad's robust offerings serve to enrich the overall health, wealth, and wellbeing of our employees and their families through the various stages of an employee's work and life cycle. We are proud to offer options including an extensive benefits package, life and disability, a Deferred Profit-Sharing Plan, extensive learning and development opportunities, an educational assistance program, fitness subsidy, time off, etc.

Who We Are: For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see.

EEO Statement: Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with physical or mental disabilities, and people of all race, color, sex, sexual orientation, gender identity, religion, national origin and citizenship status are encouraged to apply.

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