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The company:
This international Medical Device company is located nearby Breda.
They are active in multiple products and have their distribution side for the European Union also on this location.

Role description:
You will be the supervisor of the QA team and will implement the QMS, CAPA and will be responsible for the internal audits. Next to that you will develop and lead your team within the site of Quality. You will set up Quality metric reporting, investigation and quality risk assessment. 
You are a proven leader in Quality, a change manager that facilitate and support external audits. Next to that you will ensure the QA team is trained to FDA QSR, ISO 13485 / ISO 14971 and MDSAP requirements.

Responsibilities:

  • Complete quality investigation and product risk assessment for product disposition
  • Facilitate and support external audits
  • As part of the management team, support and execute cost of quality and project improvement initiates
  • Implementation of the Quality Management System– CAPA/Deviations/Internal Audits/Complaints – in line with procedures and regulatory requirements
  • Conduct and implementation of the internal Audit programme
  • Ensure team is trained to FDA QSR, ISO 13485 / 14971 and MDSAP requirements


Requirements:

  • 5-6 Yrs experience, including previous management experience
  • B.S. or B.A. in Physical Science, Engineering, or other related discipline
  • Knowledge of applicable foreign and domestic regulations
  • Knowledge of quality auditing techniques, process and validation techniques
  • Knowledge of resource planning and project management skills
  • Personnel Staffing and Management experience
  • Problem Solving and Analysing mindset and Attention to detail

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