Quality Systems Manager/QMS Specialist

Philips Iberica SAU; Farnborough; Hybrid; GBP 45,000 - 70,000; Full time

Job summary

An agile company is seeking a Quality Systems Manager/QMS Specialist to oversee quality management systems and ensure compliance with regulatory standards. This role offers a unique opportunity to contribute to life-saving medical technologies while working in a hybrid environment. You will manage audits, harmonize quality systems, and collaborate with diverse teams across multiple locations. Join a forward-thinking organization committed to innovation and excellence in healthcare, where your contributions will make a real difference in the lives of patients and healthcare professionals.

Benefits

Yearly Performance Bonus

Flexible Working Hours

Competitive Salary

Qualifications

• Experience in the medical device industry with a focus on quality management.
• Strong understanding of regulatory standards like ISO13485 and FDA QSR.

Responsibilities

• Manage site Quality Management Systems and compliance with FDA regulations.
• Collaborate with cross-functional teams and provide training and guidance.

Skills

ISO13485 Standards

FDA QSR

Quality Management Systems

Root Cause Analysis

Cross-Functional Team Collaboration

Analytical Skills

Education

Bachelor's Degree in a Scientific Field

Job description

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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For more information, read our Inclusion and Diversity Policy and view this report to learn about your Human Rights.

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