QMS Manager

This role can be fully remote and work from anywhere in the US. 

In this role, you will have the opportunity to:

• Maintains, enforces, and manages a compliant and effective QMS for the activities in scope, as well as for effective and lean QMS structures and documents for Q&R processes at all levels of Health Tech.

• Manages the transition/ deployment of the global PQMS and manage its deployment on the local level.

• Ensures proper audit planning and schedule meets the requirements of internal policies and external regulations.

• Locally manages plan for all QMS parts in scope while maintaining compliance and effectiveness throughout the duration of the transition to the global PQMS.

• Ensures the addition and management of any local QMS documents in line with the evolution the PQMS.

• Ensures training and training registration as per the QMS and generates training content for local QMS documents as necessary.

• Frequently interacts with subordinate supervisors, customers, and/or functional peer group managers, normally involving matters between functional areas, other company divisions or units, or customers and the company. Often must lead a cooperative effort among members of a cross functional project team

You will be responsible for:

• Ensures compliant and effective QMS’s are maintained in scope.

• Accountable for the transformation of all current QMS’s parts in scope towards the single PQMS structure.

• Accountable to manage and harmonize all QMS management processes and ensure the FDA-compliant validation of all SW systems in scope.

• Manages (local) Q&R processes and ensures (local) process ownership for all activities under the PQMS governance in scope.

• Ensures Q&R requirements are effective in all processes in scope.

• Ensures Document Control is established and ensures training profiles are assigned and enforced and training administration is established within scope.

• Provide support in all areas for internal and external inspections

To succeed in this role, you should have the following skills and experience:

• Minimum of three years of similar work experience.

• Experience working in disciplined regulated industry and in applying automated technology

• Experience validating activities for applications

• Experience with business application implementation projects, including being an active contributor on projects with scheduled deliverables.

• Demonstrated ability to understand and develop processes.

• Demonstrated ability to interact and communicate in English, including demonstrable writing, speaking, and comprehension skills; ability to communicate across levels of the organization

You will be a part of:

You are empowered to use your voice and expertise to have a positive impact on your team, the business, and health technologies that will improve the health, well-being and care for people around world.  You will be part of the Hospital Respiratory Care PQMS team. 

In return, we offer you:

Philips welcomes you to a challenging, innovative environment with great opportunities for you to explore and grow.

Quality is on the top of Philips leadership agenda and that means you have the unique opportunity to come in and have a recognized voice to drive and witness exciting, transformational changes. You will be empowered to drive high quality, groundbreaking innovations with a globally recognized, premium brand behind you. And when you are successful in this role you will have an array of diverse career opportunities open to you – across different functional areas, product lines, business groups and/or geographies. That is a commitment Philips Quality Leadership team has made and stands by.

Why work on a project at Philips?

If you’re looking for meaningful work and a chance to tackle complex challenges, broaden your skills and expertise and become an even more sought after professional, you’ll find all that and more with project work at Philips.

The Randstad companies are responsible for finding talent to provide services at Philips. If you are selected to provide services for Philips, you will be employed by Randstad and will not be an employee of Philips.