Q&R Manager

Q&R Manager
Formulates and implements the Business’ long-range quality, regulatory and compliance policy, and to lead and direct organizational development and process improvement in such a way as to ensure that the Business strategic policy and strategic growth targets are met.
Your role:

• To formulate and implement the Business’ long-range quality, regulatory and compliance policy
• Create Q&R awareness level as determined within the organization.
• Enforces (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.
• Manages compliance to FDA regulations and other Regulatory Agencies as required, guidelines and policies to all products and operations are consistent with those regulations.
• Manages the review and approval of finished products manufactured for and by the company in accordance with their approved specifications.
• Manages all inspections and questions relating to the product development process in coordination with all other applicable company groups
• Supports product recall activities to include recall policies and procedures for the company. Additionally, support product compliant activities and processes
• Support the Audit Program for the organization
• Drafts and manages the strategic improvement processes (‘breakthrough Program’) in the Business (One Page Strategy, Hoshin Plan).
• Interact with all areas involved in the product development process, customer services and sales and marketing and provide direction and consultation

You're the right fit if:

• 15 years of experience in product development in regulated industry such as medical devices with electro-mechanical products with embedded systems.
• 5 years of experience in managing team of engineers. Understanding of regulations and standards used in Medical Device design and development activities
• Experience with FDA inspections/ ISO audits is desired.
• Engineering professional with bachelors or masters degree electrical/mechanical engineering

How we work together
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week.
- Onsite roles require full-time presence in the company’s facilities.

- Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.
This is an onsite role.
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.
• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
If you’re 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 here.

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