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Post Market QARA Manager

Date: Nov 18, 2020

Location: Waterloo, ON, CA

Company: Agfa-Gevaert NV

Agfa HealthCare, is a division of the Agfa-Gevaert Group which is headquartered in Mortsel, Belgium and traded on Euronext Brussels (AGFB).

 

At Agfa HealthCare, we support healthcare professionals across the globe to transform the delivery of care. Our focus is 100% on providing best-of-suite Imaging IT software solutions that enable secure, effective and sustainable imaging data management. 

 

From product development to implementation, our unified Enterprise Imaging Platform is purpose-built to reduce complexity, improve productivity and deliver clinical value. We use our proven track record as an innovator, our in-depth medical knowledge and our strategic guidance to help healthcare providers achieve their clinical, operational and business strategies.

 

The Post Market QARA Manager will support, drive and monitor Quality System aspects related to any post market related activity. This will include but is not limited to Product Deployments, Complaint Handling, Problem Management, Post Market Surveillance, Clinical Evaluations / Clinical Research, Vigilance Reporting, Internal Audits and Quality System Maintenance. This is carried out through a detailed understanding and application of QMS principles as described in Agfa’s quality management system and Global Quality System Regulations.

 

Main Responsibilities

 

  • After Sales / Deployment process management: consult and provide oversight to ensure Agfa’s Post Market processes are compliant with, implemented and adhered to the applicable standards and global regulations
  • Post Market Surveillance: collect data, analyse data, report on the data and initiate the appropriate actions
  • Vigilance process management: actively process any necessary vigilance activities within strict timelines set forth by global regulations
  • Internal audits: participate in internal audits across our quality management system
  • Quality Management System: participate in QMS activities (NCs, CAPAs) related to any of the Post Market process areas as well as Quality System maintenance and reporting.
  • Participating in Clinical Evalutations of our products which includes clinical literature searches etc.

 

Education

University degree in science or related field, or an equivalent combination of education and relevant experience.

 

Experience

  • 3-5 years’ experience in a regulated industry, preferably medical device, pharmaceutical or related in one of the following positions:
  • Regulatory analyst
  • Quality management
  • Quality assurance
  • Quality Auditor
  • Project Management
  • Clinical research
  • Facilitation and project management skills
  • Knowledge of ISO 9001, ISO 13485, ISO 20000 (ITIL), FDA QSR, EU MDR and others
  • Internal auditing
  • Knowledge in a healthcare related field
  • Ability to analyze, understand, and interpret regulations and standards for a more general business audience
  • Ability to proactively work to deadlines and attention to detail
  • Knowledge of software development methodologies is an asset
  • Clinical knowledge of the use of Image Management Systems is an asset

 

Specific skills
  • Excellent communication – verbal and written – research, organizational etc
  • Excellent interpersonal, collaboration, negotiation, conflict resolution, relationship-building, and communication skills
  • Thorough knowledge of applicable regulatory legislation
  • Comfortable presenting recommendations to individuals or groups, including development and delivery of formal training materials and presentations
  • Being able to deal with strong willed individuals in a fast paced environment

 

 

 

We offer a rewarding career in a field that impacts lives, the opportunity to work with a talented and  committed team of individuals, training and career development programs, and a competitive compensation and benefits package. If you want to be part of this experience, we'll take you there!

 

Agfa Inc. is committed to complying with the Accessibility for Ontarians with Disabilities Act 2005 (AODA) and all of its standards in order to create a barrier-free Ontario.  We will provide necessary accommodation during the recruitment and selection process to all applicants. If you require accommodation as part of the employment application process, please contact agfahealthcarehrna@agfa.com.

 

Learn more about Agfa HealthCare and follow us on Instagram.


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