• 30 januari 2020
  • Vacaturennummer lv-73265
ACIST Europe Logo Recruitment profile
ACIST Medical Systems, a Bracco Group company, is a pioneering interventional and diagnostic technology company with a portfolio of advanced products, including the world’s Rapid FFR and High Definition IVUS systems. ACIST is also a global market leader in advanced contrast imaging systems for cardiovascular angiography.
At every level of our operations, we are focused on our shared vision to be a leading provider of innovative diagnostic and interventional products and services that enable the interventionalists and their clinical team in providing superior patient care.
We are an international company with products in over 45 countries, providing high quality systems and award- winning customer support across the globe. ACIST employs over 400 people worldwide working from our corporate HQ in Minnesota, our Asian offices in Shanghai and Tokyo, our European HQ and Service & Distribution Center in Heerlen (Netherlands). We have a well-established global distribution network and direct Sales & Clinical Teams in the USA, Germany, France, UK and the Benelux.
We care as much about our employees as we do our patients. Our culture fosters a work environment where employees can thrive, be passionate and have fun along the way. Each member of the ACIST team has the power to make a difference…. every day!

POST MARKET SURVEILLANCE SPECIALIST


Position Summary:
We are looking for a Post Market Surveillance Specialist, to strengthen our Quality Team.

Responsibilities Post Market Surveillance Specialist
Support and maintenance of post-market activities associated with customer complaints:
  • Managing the overall complaint process to ensure timely processing of complaints
  • Monitoring and following up complaints in TrackWise, including Triage – Review - Closure
  • Determine reportability related to patient risk and safety for every reported complaint
  • Identify complaints requiring investigation and coordinate cross-functional tasks to facilitate complaint investigations in collaboration with the Post Market Team.
  • Handling and responding to questions and requests of internal staff (Customer Service, Technical Service, and Logistics) ACIST field staff and EMEA distributors.
  • Review complaint documentation as needed to ensure that all required activities are properly completed and documented prior to complaint closure.
  • Participate in all necessary training programs and personal development programs.
Required Skills:
Minimum:
  • Degree in (MBO+/HBO), MTS/HTS
  • Affinity with quality and/or a technical background (Mechanical or Electrical).
  • Customer and Quality focused mentality.
  • Work experience in the medical device industry.
  • Strong verbal communication skills
  • Ability to develop clear, concise, and timely written reports.
  • Ability to communicate (oral and written) in English
  • You have a high sense of responsibility, are pro-active and are able to work independently and act as a Team player.
  • SAP experience
Preferred
  • Knowledge of and effective application of quality tools
  • Familiarity with quality system requirements
  • Ability to respond to common inquiries or complaints from customers
  • Internal Audit experience
  • Trackwise
If you choose to join ACIST, it applies that you like to be a part of an enthusiastic team, working with colleagues. You like to work in a changing environment with challenges along the way. You feel connected to our 3 core values, Innovation, Authenticity and Drive, and you are up to a new challenge. You can share your resume with Silvie Swillens at silvie.swillens@bracco.com

Curious about ACIST and its business? Do not hesitate to visit our company website for more information: www.acist.com