Job Title
Quality Systems Manager/QMS Specialist
Job Description
In late January, we announced that Bridgefield Capital signed an agreement to acquire Philips’ Emergency Care business which includes leading brands and products like HeartStart AEDs, Intrepid and DFM100 monitor defibrillators, Tempus monitor and Tempus ALS systems, and Corsium and ECI informatics solutions. We expect the transaction to close at the end of 2025.
With Bridgefield’s support and building on our 40+ year legacy of growth and innovation in emergency medical technology, the Emergency Care business will continue passionately pursuing our mission of saving lives, lowering the cost of healthcare, and advancing the science of resuscitation while serving the public access AED, EMS, military, and hospital market segments.
In this role and as part of an agile company that has the dedicated resources needed to achieve its strategic goals, you’ll have every opportunity to become a part of the “NewCo” we are forming and grow both personally and professionally and potentially make an even bigger impact on the acute care space – as well as on the consumers, patients and healthcare workers who depend on these innovative life-saving solutions.
Your role:
* Manage the site Quality Management Systems, CAPA, Audits and certificates providing recommendations to management, PMS, Engineering and production teams.
* Own quality systems and harmonize them across the business; establish an effective Management Review process, including routine reporting.
* Manage compliance to FDA regulations and other Regulatory Agencies as required, ensuring guidelines and policies to all products and operations are consistent with those regulations.
* Ensure proper audit planning and scheduling meets the requirements of internal policies and external regulations.
* Interact with all areas involved in the product development process, customer services and sales and marketing and provide training, direction and consultation.
* This role offers you chance for hybrid working from our vibrant & exciting new offices in Farnborough, Hampshire. Additionally, we are open to discuss flexible working requirements to better support your work-life balance.
* From competitive salary and yearly performance bonus. Be sure to speak to your recruiter about all the benefits on offer.
You’re right for this role if you have a:
* Bachelor’s degree in a scientific or technical field.
* Experience in the medical device industry with a good understanding of ISO13485 standards, EU MDD and FDA QSR.
* Career focused on Quality Management Systems and internal/external audits.
* Experience in corrective and preventive actions, including root cause analysis, documenting findings/actions, and implementing actions.
* An ability to work with cross-functional teams across multiple work locations and effectively communicate with senior stakeholders.
* Solid Organizational and Analytical skills - demonstrated ability to troubleshoot complex process/system issues and manage multiple priorities.
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.
Because we are at our best when you are, you can safely share any reasonable tools or adjustments needed during our recruitment process and beyond.
For more information, read our Inclusion and Diversity Policy and, to know more about your Human Rights, we encourage you to view this report.
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