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Quality Management System (QMS) Manager

Date: Jan 19, 2019

Location: Waterloo, ON, CA

Company: Agfa-Gevaert NV

 

Agfa HealthCare, a member of the Agfa-Gevaert Group, is a leading global provider of diagnostic imaging and healthcare IT solutions. The company has nearly a century of healthcare experience and has been a pioneer on the healthcare IT market since the early 1990's. Today, Agfa HealthCare designs, develops and delivers state-of-the-art systems for capturing, managing and processing diagnostic images and clinical/administrative information for hospitals and healthcare facilities, as well as contrast media solutions to enable effective medical imaging results. The company has sales offices and agents in over 100 markets worldwide.

 

The QMS Manager will support, 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 Audit, Quality Management Review, Document Control. This is carried out via the detailed understanding and application of QMS principles as described in Agfa process and Global Quality System Regulations.

 

Major responsibilities:

  • Implement, monitor and support the Agfa CAPA and Nonconformity process. Drive individual CAPAs and NCRs to closure according to agreed work instructions and timelines.
    • Evaluate, assign owners and drive the progress of submitted CAPAs and NCRs
    • Registration of CAPAs and NCRs 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.
    • 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.

 

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
  • Facilitation and project management skills.
  • Knowledge of ISO 9001, ISO 13485, FDA QSR, 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.
  • Knowledge of software development methodologies is an asset.

 

Required 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

 

 

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, please reach out to Human Resources.

Learn more about Agfa HealthCare and follow us on Twitter.


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