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▷ Immediate Start! Manufacturing Change Coordinator (MCC)- Medical Device

▷ Immediate Start! Manufacturing Change Coordinator (MCC)- Medical Device

Viridis Atom ConsultancyIndia
20 hours ago
Job description

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
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    Immediate Coordinator • India

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