Project Leader Quality Management

Spoločnosť: Checkmark Labrecruitment
Typ práce: Full-time
Waar ga je aan de slag - Where will you work
Our client in Amsterdam is a molecular diagnostics company focused on the development and commercialization of innovative detection products. These are used for diagnostic and research applications in the life sciences and healthcare industry. These applications include cytogenetics, microarrays, and proteomics.
Wat ga je doen - What will your job be
In this challenging role as Project Leader Quality Management you provide Design Control guidance to (new) product development while you act as the single point representative for all Quality Management activities for R&D Project teams. Interested? Apply now!
As Project Leader Quality Management you act as the single point representative for all Quality Management activities for R&D Project teams. Working together with SOP owners and QMS leaders, you support all R&D activities related to IVDR transition making sure that all processes are designed according to IVDR regulations. Once the IVDR transition took place, you should be able to fill in the role as (Senior) Scientist being involved in new product development and optimization. Your responsibilities include:
  • Provide Design Control guidance to (new) product development
  • Convey information from meetings and other communications to Quality Management to assure consistent feedback to teams and inform management of critical issues
  • Review and approve documentation consistent with design control regulations, guidance and QMS policy
  • The documentation include Design History Files (DHF), customer- and product requirements, design- and development- plans, design transfer documents, risk management reports, (non)-clinical protocols etc.
  • Participate in difficult discussions and identify mutually benificial compliant solutions at Project Team level. Therefore you work closely together with DQA colleagues
  • Be the author of Quality reports, and advise project teams during the planning of milestones
Wat vragen wij - What are we looking for
For the position of Project Leader Quality Management we are looking for a candidate who combines design control and R&D expertise, with strong experience under established quality regulations. You meet the following requirements:
  • MSc or PhD degree in Chemistry, Biochemistry, Moleculair or other related scientific discipline
  • At least 5 years of relevant work experience under estabilished quality regulations
  • Working knowledge of QSR/cGMP, ISO13485 and Design Controls
  • Knowledge of medical device or pharma processes
  • Strong track record of succesfull participation in cross-functional teams
  • Fluent language skills in Dutch and English

Wat hebben we te bieden - What do we offer
  • Long term position, which starts with a one year contract at the hiring company
  • Full-time position, where 32 hours a week is negotiable
Wil je meer weten - More information
Neem voor meer informatie contact op met Jurjen Wilschut: //
Vacaturenummer: 7220
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