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Postmarket QARA Professional (m/w/d)

Date: Feb 10, 2019

Location: Bonn, DE

Company: Agfa-Gevaert NV

Agfa HealthCare is a global leader in IT enabled clinical workflow and diagnostic imaging solutions, offering healthcare facilities a seamless flow of information and a 360º view of patient care.

The company has a unique, holistic approach, enabling it to provide in-depth clinical know-how and fully integrated hospital-wide solutions.

 

 

For our office in Bonn we are looking for a

 

Post Market Quality and Regulatory Manager (m/f/d)

 

 

Your Challenge:

 

Embedded in the global Quality and Regulatory Team, you ensure regulatory compliance of our post market activities, managing our Health IT software medical devices.

As key member of our international Product Quality Management Teams you safeguard the resolution of customer complaints escalated for our medical devices and other business critical products.

You drive and guide the cross functional teams addressing product issues and defining and implementing effective preventive and corrective actions.

Your regular trend analysis reporting on product quality in our customer base supports senior management in taking effective decision for quality improvements.

In our fast-growing business segment, your regulatory consulting is key in continuous improvement of our business processes.

 

 

Your Profile:

 

  • University Degree (Engineering, Computer Science or Science) or equivalent from experience
  • Minimum 3-5 years’ experience in a regulated industry – preferably medical device or related – in project management, analyst, technical support, quality management, or quality assurance and regulatory affairs position
  • Familiar with international regulations and standards pertaining to medical devices development and servicing; familiarity with ISO 9001, ISO 13485, ISO 14971 and ability to interpret and work with regulations and standards
  • Exposure to risk management processes, CAPA and software development
  • Team player with excellent interpersonal, collaboration, negotiation, conflict resolution, relationship-building, and communication skills
  • Self-starter attitude, strong organizational skills, and the ability to meet deadlines
  • Knowledge of data analysis and statistical techniques
  • Very good German and English verbal and written language skills, French is an asset
  • This position offers stepwise growth, so senior, professionals and junior profiles are welcome

 

We offer a rewarding career in a field that impacts lives, the opportunity to work with a talented, committed team of individuals, training and career development programs, and a competitive compensation and benefits package.    

 

     If you want to be part of our world and future, we'll take you there - we are looking forward to receiving your application (cover letter, cv, testimonials)!

 

 

 

Agfa HealthCare GmbH
Human Resources
Konrad-Zuse-Platz 1-3
53227 Bonn
http://global.agfahealthcare.com/dach/jobs


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