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.