Manufacturing Change Coordinator (MCC)- Medical Device

Company Description

Viridis Atom is focused on consulting engagements in the healthcare segment.

Role Description

This is a full-time role for a Manufacturing Change Coordinator (MCC) and will be at site of a prominent medical device multinational client.

This role is NOT SUITABLE for job seekers WITHOUT medical device industry experience.

Responsibilities

• Good understanding of medical device GMP. Awareness of ISO 13485 / FDA QSR
• Manufacturing Change coordinator to work with cross functional team to implement Engineering and manufacturing changes for site.
• Implement the changes following the check list and QMS requirements
• Participate in change control meetings (Global & Local), initiate and track actions
• Drive local change control meetings with cross functional teams, publish MOM & track actions.
• Lead QMS (Quality Management Systems), Regulatory audits on change control at site
• Implement QMS practices at site
• Own and drive nonconformities (NC), investigations, CAPA.

Qualifications :