Manufacturing Change Coordinator

WIPRO GE HEALTHCARE PRIVATE LIMITED

10 - 15 years

6 - 10 Lacs

bengaluru

Posted:-1 days ago| Platform:

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Skills Required

primary coordinator interpersonal skills medical imaging process engineering qms telecommunication healthcare iso audit ms office biomedical

Work Mode

Work from Office

Job Type

Full Time

Job Description

Act as the primary coordinator for manufacturing changes, collaborating with cross-functional teams to implement engineering and production modifications effectively for NPIs , Manufacturing Transfer and existing products.
Ensure all changes are executed in alignment with Quality Management System (QMS) requirements and regulatory standards.
Participate in global and local change control meetings, initiating actions and driving timely closure of change-related tasks.
Lead local change control forums, guiding cross-functional teams to resolve issues and implement improvements.
Spearhead the implementation of QMS practices at the site level and support regulatory audits focused on change control processes.
Partner with local and global QA teams to manage nonconformities (NCs), conduct investigations, and implement corrective and preventive actions (CAPA).
Coach and mentor the Process Engineering team on QMS principles and change control procedures to build organizational capability.

Required Qualifications

Bachelor s/master s degree in engineering disciplines (Electrical / Mechanical / Production / Industrial / Electronics / Electronics and Telecommunication/Medical Electronics/Bio Medical Engineering).
Sound knowledge/experience of medical device Quality Management System (QMS) ISO13485, FDA regulations and Design 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

Experience:

7 ~10 years in Medical Device Industry.

Desired Characteristics

ISO auditor certification

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