Quality Systems Compliance Specialist
2 months ago
**Patterson isn't just a place to work, it's a partner that cares about your success.**
One of the distinguishing marks of our company is the talented people who embrace the people-first, always advancing, and results-driven culture. Professional growth abounds in this motivating environment. We value the diverse talents and experiences our employees bring to Patterson and believe that they build a stronger and successful organization.
Patterson Dental Canada Inc. is the trusted partner of the dental industry in goods, equipment, services and technology. Our company has more than 500 employees across the Canadian territory.
**Job summary**:
The Quality Systems Specialist is responsible for maintaining and managing the daily operations of the Patterson Quality Management System. Manages quality system activities with responsibility for results in terms of ongoing effectiveness of the QMS and of conformance to applicable regulation, standard and company policies. Supports activities related to distribution, nonconforming product, post-market surveillance, field actions, and corrective actions.
**Major Duties**:
- Oversees daily operations of the QMS for compliance to requirements of applicable regulations and standards, including 21 CFR Part 820, ISO 13485, CMDR, GMPs and others as applicable.
- Proposes and implements improvements to the QMS and its procedures and processes to maintain ongoing effectiveness.
- Supports quality activities associated with the distribution process including monitoring of pest control, work environment (i.e. temperature monitoring), calibration, and nonconforming product.
- Manages Corrective and Preventive Action (CAPA) and deviation process, including records from initial investigation and root cause analysis, into action planning and effectiveness in a timely and compliant manner.
- Manages complaint review, investigation and reporting in a timely and effective manner.
- Manages field action risk assessment, bounding, inventory control, communications, effectiveness checks and reporting/closure.
- Supports documents and records control process.
- Participates in management reviews and generates quality system metrics in support of management review.
- Participates in internal/external audits and may lead supplier audits.
- Stays current on industry trends in relation to compliance.
- Provides support and contributes to other compliance activities and areas as necessary.
- Other duties as assigned.
- Occasional travel required.
**Job qualifications**:
- Bachelor’s Degree in engineering, Science or related field or equivalent work experience.
- 2-4 years' experience with quality management systems and regulatory compliance in the medical device or related regulated field.
- Excellent oral and written communication skills, in French and English.
- Developing working knowledge of quality management systems.
- Demonstrated ability to review and quickly assimilate complex regulatory compliance information and standards.
- Ability to work effectively within a team and as an individual contributor in a fast-paced changing environment - multi-tasks, prioritizes and meets deadlines in timely manner.
- Strong verbal and written communications with ability to effectively communicate at specialist and line management levels in the organization.
- Strong organizational, analytical, and creative problem-solving skills and track record contributing to teamwork practices with a moderate impact on functional objectives.
- Highly self-motivated and directed and able to carry out responsibilities with latitude and limited supervision.
- Ability to prioritize and execute tasks in a high-pressure environment.
- Strong customer service orientation.
- Experience working in a team-oriented, collaborative environment.
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**Patterson n’est pas juste un simple lieu de travail, c’est un partenaire qui se soucie de votre succès.**
L’une des marques distinctives de Patterson, ce sont les personnes de talent qui incarnent notre culture ̶ être axés sur les gens, en constante évolution et centrés sur les résultats. La croissance professionnelle abonde dans cet environnement de travail motivant. Nous reconnaissons l’apport positif de la diversité des talents et des expériences de nos employés et nous croyons qu’ils bâtissent une organisation plus forte et prospère.
**Résumé du poste**:
Le spécialiste de l’assurance qualité et de la réglementation est responsable du maintien et de la gestion des activités quotidiennes du système de gestion de la qualité de Patterson. Il gère les activités du système d’assurance qualité de façon responsable afin d’assurer l’efficacité continue du système de gestion de la qualité ainsi que la conformité à la réglementation, aux normes et aux politiques de l'entreprise en vigueur. Il soutient les activités liées à la distribution, aux produits non conformes, à la surveillance post-c
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