This vacancy is now closed
LinkedIn ShareShare
More

Medical Device QMS Manager

Profile

A global mid-size pharmaceutical company with a strong portfolio of Medical Devices, is looking to bring onboard a Medical Device QMS Manager. This newly created role, will be responsible for developing and maintaining a specific Quality Management System (QMS) for the Medical Device portfolio, that is fit for purpose, and can adapt to new regulations and business needs.

Responsibilities:

  • You will be responsible for designing, implementing and maintaining a company-wide Medical Device QMS, that can ensure the continuing compliance to regulatory requirements.
  • As Medical Device regulatory requirements evolve, you will ensure the MDQMS remains current and remains compliant.
  • You will report to senior management on the QMS performance and on any improvements that are needed.
  • As MD QMS Manager, you will continually review the QMS to ensure it ensures compliance and meets the business’s needs.
  • Perform and execute internal audits in compliance with ISO13485 and other relevant directives and regulations.
  • Ensure the company is ready for Notified Body audits.
  • You will ensure that you are constantly up to date with all relevant laws and regulations, including changes to medical device standards, practices and regulations.

Requirements:

  • You will have excellent and demonstratable knowledge of medical device regulations and standards.
  • Have experience of managing and developing a QMS.
  • Have an engineering or related degree. Further relevant postgraduate qualifications would be a bonus.
  • Have experience of medical device auditing.
  • You’ll have strong stakeholder management and presenting skills.
  • Experience of working at an above-country/regional level.

To learn more about this role, please apply or contact Matt directly on matt.smith@bluepelican.com

How to apply

If this position is of interest please send us your CV here, or you can call Matt Smith direct on to discuss this and other vacancies that may suit.

Matt Smith

Email: matt.smith@bluepelican.com