Philips Q&R Manager in Pune, India

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Role Purpose

  • To formulate and implement the Business’ long-range quality, regulatory and compliance policy, and to lead and direct organizational development and process

  • The individual will also drive sustainable improvements in such a way as to ensure that the Business strategic policy and strategic growth targets are met.

  • Ensures that all products to be released comply with relevant safety and environmental policies and regulations by implementing requirements, conditions and enablers in the Business

Key Areas of Responsibilities

  • To formulate and implement the Business’ long-range quality, regulatory and compliance policy

  • Create Q&R awareness level as determined within the organization

  • Enforce (a simplified) quality systems and harmonizes them across the Business sites and Sector; establish an effective Management Review process, including routine reporting.

  • Introduce and implement the quality processes and tools required to ensure product quality and customer satisfaction

  • Manage compliance with FDA regulations and other Regulatory Agencies as required, guidelines and policies to all products and operations are consistent with those regulations

  • Manage the review and approval of finished products manufactured for and by the company in accordance with their approved specifications

  • Manage all inspections and questions relating to the operation of the manufacturing sites in coordination with all other applicable company groups

  • Manage product recall activities to include recall policies and procedures for the company

  • Direct the Audit Program for the organization

  • Draft and manage the strategic improvement processes (‘breakthrough Program’) in the Business

  • Interact with all areas involved in the product development process, customer services and sales and marketing and provide direction and consultation

Key Performance Indicators

  • Total Quality Costs (primarily in Idea to Market & Order to Cost)

  • Business Unit quality targets

  • Significant External Inspections/audit outcomes (#)

  • Field Actions (%)

  • QMS - Integration

  • Initial Quality / Dead on Arrival (%)

  • Complaint speed of resolution rate (based on registered calls)

  • Field Failure rate (%)

  • CAPA Closure and Effectiveness

Required Competencies

  • Quality Management

  • Regulatory Management

  • Q&R Business Partner

  • Quality and Compliance Leadership

  • Business Leadership

  • Talent Development

Qualification

  • Bachelor’s degree

  • Has played people’s manager role

  • Medical devices domain knowledge

  • Experience of minimum 15 years in Q&R Field