Quality System and Regulatory Compliance specialist

At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development.

Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we’re working at the pace of change on diagnostic tools that address the world’s biggest health challenges, driven by knowing that behind every test there is a patient waiting.

Learn about the Danaher Business System which makes everything possible.

The Quality System and Regulatory Compliance Specialist is responsible for reviewing records and documents, for completeness and compliance with ISO and QSR requirements.

In this role, you will have the opportunity to:

• Review records and documents, for completeness and compliance with ISO and QSR requirements.
• Support of document control system facilitating document creation and approvals.
• Review batch record to support release of incoming goods received in quarantine status, rework and refurbished products.
• Assist with the implementation of standard operating procedures to define and improve quality system functions.
• Support interdepartmental initiatives for continuous improvement.
• Partner with departments to promote improvements, through the use of training.
• Suppor the CAPA program in the investigation and resolution of issues.
• Participate in the internal auditor program as needed.

The essential requirements of the job include:

• Bachelor’s degree with 2+ years of related work experience OR Master’s degree in field with 0-2 years of related work experience
• Excellent verbal and written communication skills (French and English)
• Knowledge of International Organization for Standardization ISO13485
• Knowledge of International regulations QSR for USA, CE Directive and Regulation for Europe
• Excellent planning and organizing skill

It would be a plus if you also possess previous experience in:

• Exceptionally strong team player with excellent interpersonal and communication skills
• Able to confidently deal with ambiguous issues and provide input towards suitable actions.

At Cepheid we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part of the time at the Company location identified above and part of the time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Cepheid can provide.

Chez Cepheid, nous sommes passionnés par l’amélioration des soins de santé grâce à des tests de diagnostic rapides et précis. Notre mission nous motive à chaque instant et nous développons des solutions évolutives et innovantes pour résoudre les problèmes de santé les plus complexes au monde. Nos associés participent à toutes les étapes du diagnostic moléculaire, de l’idéation au développement et à la fourniture de tests avancés qui améliorent les résultats pour les patients dans un grand nombre de contextes. En tant que membre de notre équipe, vous pouvez avoir un impact immédiat et mesurable à l’échelle mondiale, dans un environnement qui favorise l’évolution de carrière et le développement.

Cepheid est fier de travailler aux côtés d’une communauté de six autres sociétés de Danaher Diagnostics. Ensemble, nous travaillons au rythme du changement sur des outils de diagnostic qui répondent aux plus grands défis de santé dans le monde, en sachant que derrière chaque test, il y a un patient qui attend.

Découvrez le système commercial de Danaher qui rend tout possible.

Le/la Quality Sytem and Regulatory Compliance Specialist aide l’organisation à contrôler la conformité aux processus et normes d’assurance qualité établis. Il évalue les contrôles internes, les communications, les évaluations des risques et la tenue de la documentation en ce qui concerne le respect des normes internes et externes en matière de qualité et de réglementation. Identifie les risques et évalue les lacunes tout en collaborant avec les services internes et les unités opérationnelles pour y remédier de manière appropriée. Faciliter la formation interne aux exigences, processus et procédures d’assurance de la qualité. Il peut procéder à des audits et à des évaluations des risques.

Dans ce rôle, vous aurez l’occasion de :

Examiner les dossiers et les documents pour s’assurer qu’ils soient complets et conformes aux exigences ISO et QSR.

Soutenir le système de contrôle des documents en facilitant la création et l’approbation des documents.

Examiner l’enregistrement des lots afin de soutenir la libération des marchandises reçues en quarantaine, des produits retravaillés et remis à neuf.

Contribuer à la mise en œuvre de procédures opérationnelles normalisées afin de définir et d’améliorer les fonctions du système de qualité.

Soutenir les initiatives interdépartementales d’amélioration continue.

Travailler en partenariat avec les départements pour promouvoir les améliorations par le biais de la formation.

Soutenir le programme CAPA dans l’investigation et la résolution des problèmes.

Participer au programme d’audit interne si nécessaire.

Suivre toutes les formations assignées et requises de manière satisfaisante et dans les délais impartis.

Les exigences essentielles du poste sont les suivantes :

Baccalauréat et plus de 2-3 ans d’expérience de travail connexe en qualité OU maîtrise dans le domaine et 0 à 2 ans d’expérience de travail connexe.

Connaissance de la réglementation européenne CE

Excellentes aptitudes à la communication orale et écrite (français et anglais)

Excellentes compétences en matière de planification et d’organisation

Une expérience antérieure dans les domaines suivants constituerait un atout supplémentaire

Connaissance de l’Organisation internationale de normalisation ISO13485

Connaissance de la réglementation internationale par exemple QSR pour les États-Unis

Vous êtes capable de traiter avec confiance des questions ambiguës et de proposer des actions appropriées.

Cepheid, une société du groupe Danaher, offre un large éventail de programmes d’avantages sociaux complets et compétitifs qui ajoutent de la valeur à nos vies. Qu’il s’agisse d’un programme de soins de santé ou de congés payés, nos programmes contribuent à la vie au-delà du travail. Découvrez nos avantages sur le site danaherbenefitsinfo.com.

Chez Cepheid, nous croyons en la conception d’une main-d’œuvre meilleure et plus durable. Nous reconnaissons les avantages de la flexibilité et du travail à distance pour les postes éligibles et nous nous engageons à offrir des carrières enrichissantes, quel que soit le mode de travail. Ce poste peut faire l’objet d’un contrat de travail à distance dans le cadre duquel vous pouvez travailler depuis votre domicile. L’équipe chargée de l’entretien vous fournira de plus amples informations sur ce mode de travail à distance. Explorez la flexibilité et les défis que vous offre le fait de travailler pour Cepheid.

At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development.

Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we’re working at the pace of change on diagnostic tools that address the world’s biggest health challenges, driven by knowing that behind every test there is a patient waiting.

Learn about the Danaher Business System which makes everything possible.

The Quality Sytem and Regulatory Compliance specialist supports the organization with monitoring of conformance to established quality assurance processes and standards. Performs evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external quality and regulatory standards. Identifies risk and evaluates deficiencies while working with internal departments/business units to appropriately remedy them. Facilitates internal training on quality assurance requirements, processes, and procedures. May perform audits and risk assessments.

In this role, you will have the opportunity to:

Review records and documents, for completeness and compliance with ISO and QSR requirements.

Support of document control system facilitating document creation and approvals.

Review batch record to support release of incoming goods received in quarantine status, rework and refurbished products.

Assist with the implementation of standard operating procedures to define and improve quality system functions.

Support interdepartmental initiatives for continuous improvement.

Partner with departments to promote improvements, through the use of training.

Support the CAPA program in the investigation and resolution of issues.

Participate in the internal auditor program as needed.

Complete all assigned and required training satisfactorily and on time

The essential requirements of the job include:

Bachelor’s degree with 2-3 years of related work experience OR Master’s degree in quality field with 0-2 years of related work experience

Knowledge of CE Directive and Regulation for Europe

Excellent verbal and written communication skills (French and English)

Excellent planning and organizing skills

It would be a plus if you also possess previous experience in:

Knowledge of International Organization for Standardization ISO13485

Knowledge of International regulations e.g. QSR for USA

Able to confidently deal with ambiguous issues and provide input towards suitable actions.

Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at danaherbenefitsinfo.com.

At Cepheid we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Cepheid can provide.

At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

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