Quality Management Project

LausanneTemporärChemie, Pharma, Biotechnologie2019-01-11Master / Universität
We are Recruiting for a 12 months contract a QMS Project Manager to be an active part in the QMS implementation.

Quality Management Project

Your Responsibilities

  • Develop and implement the QMS at the company site for Quality Harmonization Project
  • Evaluate and develops current quality processes for business alignment.
  • Support and Implement quality process improvements.
  • Key contact from Harmonization Project for promotion of change
  • Provide training and expertise in the awareness of quality processes for all relevant employees.
  • Support and monitor quality processes improvement.

Main tasks:
  • Project manage process improvement and efficiency with regards to compliance activities in QMS
  • Implement, manage and monitor process workflows in QMS to ensure compliance.
  • Provides training and support for all staff in the day-to-day management of project harmonization.
  • Communicates with cross-functional team's field staff and global partners as required to support QMS project harmonization and other process activities.
  • Provide regular updates to management and timelines.
  • Facilitates with support training and documentation for each workflow within the framework of the project.
  • Reviews and updates quality documentation in accordance with the ISO 13485, MDR and the FDA quality system regulation and the applicable regulatory requirements.
  • Generates and oversees analysis and reporting of regular reports , management reviews and in response to internal requests and for the project.

Your Profile

  • Bachelor's degree in Science, Engineering, Quality or equivalent discipline
  • Ideally 7-10 years medical device industry experience in Quality Management
  • Change management experience
  • Project Management
  • Quality System tool experience
  • Fluent English
  • Working knowledge ISO 14971 Risk Management and MDR
  • Demonstrated proficiency with Microsoft Excel.
  • Working knowledge and experience with quality systems regulations and guidelines, ISO 13485, and FDA quality system regulations 21CFR 820.

Votre contact

Etes-vous intéressé(e)? Vous pouvez postuler soit en ligne, soit par eMail.

Merci de préciser la référence JN -122018-294349