Back to Job Search

Quality Manager

Job Description

Melio Life Science has partnered up with a leading Medical Device Company seeking a highly skilled Quality Manager to join their dynamic team.

Overview

As Quality Manager you will be leading your team and collaborating with other departments in ensuring FDA regulations are met.

Responsibilities

  • Develop and Maintain a QMS according to FDA requirements.

  • Lead a manufacturing Quality group

  • Lead Corrective and Preventive Action (CAPA) programs, ensuring timely and effective resolution of issues.

  • Carry out internal and external audits

  • Collaborate closely with regulatory affairs to ensure timely submissions and approvals

Qualifications

  • 10 + years’ experience in Quality

  • 10+ years’ experience in Medical Device

  • 2 years’ experience in a management position

  • Strong leadership and communication skills

  • Experience in EU MDR is strongly desirable