QMS Quality Manager
QMS Quality Engineer (Randstad Contingent Worker)
Actual Job Title: QA Engineer II
This role is onsite with a hybrid schedule at the Carlsbad, CA location.
In this role, you will have the opportunity to:
Supporting Quality Management Planning activities to ensure continued compliance, visibility, and appropriate planning for changes impacting the QMS.
You will be responsible for:
- Ensuring that the Quality Management System is created in compliance with the appropriate Philips Policies, standards and regulations required by the products supported.
- Maintaining the Quality Management System structure to ensure compliance to Philips Policies, including but not limited to, ISO 13485, 21 CFR 803, 806 and 820, and EU Medical Device Regulations.
- Maintaining and enforcing 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.
- Supporting the Philips Quality Management System (PQMS) Framework and managing deployment.
- Ensuring proper audit planning, preparation, and scheduling meets the requirements of internal policies and external regulations.
- Ensuring Document Control is established and ensures training profiles are assigned and enforced and training administration is established within scope
- Ensuring the FDA-compliant validation of all SW systems in scope.
To succeed in this role, you should have the following skills and experience:
- US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
- Bachelor’s degree in a quality or business field - highly preferred
- 4+ years of experience in the medical device or similar highly regulated industry - highly preferred
- Strong understanding of the regulations and requirements governing the establishment and maintenance of a Quality Management System
- Solid Analytical skills - demonstrated ability to trouble-shoot complex process/system issues.
- Experience in corrective and preventive actions, including root cause analysis, documenting findings/actions, and implementing actions.
- Excellent communication, organizational and project management skills.
- Successful experience working with cross functional teams across multiple work locations.
You will be a part of:
An organization that believes what you do every day can contribute to the innovative health technologies and solutions we develop that make a positive impact on billions of people every year. Including you. Because you will find when you work at Philips that your professional and personal lives often intersect in unexpected and fulfilling ways. It is our mission to improve people’s lives through meaningful innovation and we want you to play a central role in this by leading teams, driving projects, thinking strategically and inspiring colleagues from all over the world.
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.