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 :

Should have worked hands-on in a medical device industry either in a QA, RA, Design or Manufacturing Engineering for at least 2 years. Max experience is 6 years Trainee experience will be considered. This is a non-negotiable requirement

Bachelor’s degree in Any branch of Engineering.

Sound knowledge / experience of medical device Quality Management System (QMS) and Change control process.

Good communication skills (Oral / Written)

Effective multitasking and ability to deliver on time and with quality.

Ability to work in a team with good Interpersonal skills

Hands on experience on Microsoft office applications

Auditor Certification - Desired