Jobs in life sciences

QA consultant/ business developer/business unit manager/ IVDR and MDR for MindCapture

Ref. 168
Function: Consultancy in QA projects at customer's site/ customer acquisition
Location: Offices at Ghent or Antwerp, business development and projects at customer’s site in Flanders. Leading the QualityCapture department.

The company:

Talent & content

MindCapture has its offices in Ghent and Antwerp and focuses on innovative environments and future oriented life science talents.
We provide staffing (talent) and consultancy services (content). 

QualityCapture: https://www.mindcapture.com/content#quality-capture

Our QualityCapture team consists of experienced quality management consultants who developed their hands-on experience and expertise over the past 15 years. We can help you with a specific quality management request or we can offer a total, customized solution. We are highly skilled in the area of medical devices, medical labs, healthcare services, CRO, pharma and biotech.

Job description:

For our QualityCapture team, we are looking for a QA consultant/ business development manager/ business unit manager to strengthen our team. 

  • You will look for new accounts, you make proposals and follow up in needs in the market in order to enlarge our customer base (lead generation, contracting and business development). 
  • You will monitor customer satisfaction as a basis for continous improvement of our service proposal. 
  • You will support in setting up, improving or reorienting the customer’s QMS (as-is analysis, gap analysis and set-up of a fit for purpose QMS).
  • You will validate software (according to GAMP5 methodology), instruments, reagent control, methods and processes. 
  • You will focus on data integrity in compliance with international standards, guidelines, regulations or GxP, as well as document control, training and personnel, complaint and CAPA handling. 
  • You will support risk management. 
  • You support the client in finding the solution that best matches the client’s needs, in alignment with the available time, budget and resources.
  • You will use various tools that are needed to support QMS such as document control and LI(M)S. 
  • You will work in an agile way using a stepwise project management methodology. 
  • You will operate in a pragmatic and solution/result-driven way. 
  • You will perform internal and supplier audits. 
  • You will steer continuous improvement and satisfy processes by setting up and periodically reviewing metrics and KPIs.
  • You will advise and design the management review.  
  • More info: https://www.mindcapture.com/content#quality-capture. 

Requested competences and skills:

  • You have a background in life sciences. 
  • You have a good understanding of QA in medical devices or medical labs or healthcare services or CRO or pharma or biotech. Quality is your passion!
  • You have experience with one or more of following QMS standards: ISO9001, ISO17025, ISO15189, GCP, GCLP, GMP, ISO13485, ISO14791, IEC62403 or EU MDR 2017-745/746. 
  • You have an open mind for business development.
  • You have a minimum of 3 years of experience with QA. 
  • You are fluent in Dutch and English (speaking and writing). 
  • You are able to take the lead and to motivate others in order to follow QA guidelines.
  • You have strong communicative skills in order to talk with different stakeholders. 
  • You are willing to travel across Flanders to perform consulting activities at the customer’s site. 
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