Manager – Quality

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Job Function:
Quality

Job Sub Function:
Customer/Commercial Quality

Job Category:
Professional

All Job Posting Locations:
Mumbai, India

Job Description:

Overall Purpose of Job:

Leads the Commercial Quality & Compliance organization in MedTech for Surgery Business Unit and provide leadership & strategic direction to the Surgery CQ Team to establish, maintain and improve quality assurance programs for India and neighboring markets (Sri Lanka, Bangladesh, Bhutan, Maldives and Nepal).

Plans, coordinates, and directs quality assurance programs designed to ensure continuous production of products, handling of products by Supply Chain / Deliver partners consistent with established standards by performing the duties personally or through subordinates.

The responsibility covers for Surgery Business Unit and EP (Electrophysiology) business as part of the Hosting Model under Project Optimize.

Key Responsibilities:

1) Responsible for India overall Quality Management and daily Commercial Quality operations -

a) Acts as Management Representative (MR) for JJMTI business.

b) Works with regional commercial quality leadership teams to drive regional Q&C and India commercial strategies to support India business

c) Establish effective local marketing company quality management systems that drives proactive quality, robust corrective action and preventive action (CAPA) and risk management processes.

d) Ensures that performance and quality of products conform to established company and regulatory standards.

e) Manages the qualification and validation for all products and processes and quality control support activities.

f) Ensure compliance to all quality standards and regulatory requirements, manage internal and external audits to validate compliance and identify opportunities for improvements.

g) Drive quality performance and quality continuous improvements

2) Accountable on routine Commercial Quality Operations -

a) Maintain quality management system and ensure compliance on every stage of the operations such as but not limited to :

i) post market surveillance activities in complaint management, adverse event reporting

ii) Conduct gap ass...