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Manufacturing Change Coordinator (MCC)- Medical Device
Viridis Atom Consultancypune, maharashtra, in11 hours ago
Job descriptionShould 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
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 :
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Device Device • pune, maharashtra, in