Job Description

Job Title QMS Manager



Job title:
One sentence description of role

Your role:

• In this role, you will be responsible for establishing & maintaining effective Quality Management Systems (QMS) in accordance ISO 13485 & 21 CFR 820 requirements for factories in Pune.
• Supports the MS-QMS Owner and the Management Representative in defining the MS-QMS Strategy
• Secures adherence to MS-QMS processes and procedures.
• Manages Intracompany Quality Agreements (ICQA),
• Manages certification of the MS-QMS (when applicable) and liaises with Certification Partners as needed including reporting Substantial changes to the MS-QMS
• Assembles relevant reports and data for input to Management Review
• Accountable for the transformation of all current QMS\xe2\x80\x99s parts in scope towards the single PQMS structure.
• Accountable for availability of metrics/KPI data to for periodic review
• Maintain validation status for QMS softwares.
• You will be based out in factory and closely work with Plant Quality leader, leadership team, global deployment teams, Global QMS leads.

You\'re the right fit if: (4 x bullets max)

• Bachelor\xe2\x80\x99s degree with 7 + years of industrial experience, experience in medical industries is a plus
• You have strong hold on ISO 13485, 21 CFR 820 requirements & Understanding on global standards & regulation like EU Medical Device Directive (93/42/EEC), European Medical Device Regulation, and MDSAP (including all member countries regulations) .
• You have ability to interact professionally with all organizational levels, interact with global teams, drive QMS programs and initiatives
• You\xe2\x80\x99re an individual with strong communication skills including written, verbal and listening; and have excellent organizational skills with the ability to multi-task and effectively prioritize your workload

About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won\'t stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.

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If you\xe2\x80\x99re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion .

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