Job Title
Quality Systems Manager/QMS Specialist
Job Description
Quality Systems Manager/QMS Specialist
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, as part of an agile company with dedicated resources to achieve strategic goals, you’ll have the opportunity to be part of the “NewCo” we are forming, grow both personally and professionally, and potentially make a significant impact on the acute care space and on the consumers, patients, and healthcare workers relying on these 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 with FDA regulations and other regulatory agencies, ensuring all products and operations adhere to relevant guidelines and policies.
* Plan and schedule audits to meet internal policies and external regulatory requirements.
* Collaborate with all areas involved in product development, customer service, sales, and marketing, providing training, guidance, and consultation.
* This role offers hybrid working from our new offices in Farnborough, Hampshire, with flexibility to support work-life balance.
* Enjoy a competitive salary, yearly performance bonus, and other benefits; discuss these with your recruiter.
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.
* Focus on Quality Management Systems and internal/external audits.
* Experience with corrective and preventive actions, root cause analysis, documentation, and implementation of actions.
* Ability to work with cross-functional teams across multiple locations and communicate effectively with senior stakeholders.
* Strong organizational and analytical skills, with the ability to troubleshoot complex issues and manage multiple priorities.
If interested and you have many, but not all, of the required experiences, we encourage you to apply. You may still be a suitable candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.
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