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