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Senior Quality Systems Manager

Date:  Sep 13, 2021
Location: 

Waterloo, ON, CA

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 Senior Quality Management System (QMS) Manager will drive and monitor all Quality System aspects for Agfa HealthCare Globally. This will include but is not limited to Corrective and Preventative Action (CAPA), Nonconformity process, Internal and External Audit, Quality Management Review and Document Control. This is carried out via the detailed understanding and application of QMS principles as described in Agfa’s process and International standards & regulations.

 

This position can be based in Waterloo, Canada or in Mortsel, Belgium

 

Major Responsibilities:

 

  • Implement, monitor and support the Agfa CAPA and Nonconformity process. Drive individual CAPAs and NCs to closure according to agreed work instructions and timelines.
    • Evaluate, assign owners and drive the progress of submitted CAPAs and NCs
    • Registration of CAPAs and NCs in an eQMS management tool
    • Train others on and drive the root cause analysis of issues
    • Perform effectiveness checks for CAPAs
  • Preparation, scheduling, execution and reporting of internal, supplier, and external audits including audit results.
    • Act as the primary contact with Agfa’s Notified body in line with corporate direction and changing regulatory environment.
    • Support the management and closure of findings throughout the organization
  • Support the business in creating, maintaining / reviewing QMS documents via approved document control processes.
    • Create work instructions for others as required
    • Provide expertise on best practice related to QMS application
  • Work with others to create and deliver QMS focused training as needed.
  • Maintenance and tracking of key QMS related metrics, and presentation of such quality results to Executive Management.
  • Represent AGFA’s QMS activities during external audits.

 

Education:

 

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

 

Experience:

 

  • 7+ 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
  • Facilitation and project management skills.
  • Knowledge of ISO 9001, ISO 13485, FDA QSR, MDSAP, EU MDR.
  • 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.
  • Experience in a software development environment is an asset.
 
Specific skills:

 

  • Excellent communication – verbal and written – research, organizational, and interpersonal skills.
  • 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

 

Major Contacts:

 

  • QARA Leadership
  • Business Process Managers
  • Business leadership teams
  • All Agfa HealthCare departments

 

 

 

 

 

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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