JOB DESCRIPTION
Job Title
Quality Systems Manager/QMS Specialist
Job Description
Quality Systems Manager/QMS Specialist
Your role:
1. Manage the site Quality Management Systems, CAPA, Audits and certificates providing recommendations to management, PMS, Engineering and production teams.
2. Own quality systems and harmonize them across the business; establish an effective Management Review process, including routine reporting
3. Manage compliance to FDA regulations and other Regulatory Agencies as required, guidelines and policies to all products and operations are consistent with those regulations.
4. Ensuring proper audit planning and scheduling meets the requirements of internal policies and external regulations
5. Interact with all areas involved in the product development process, customer services and sales and marketing and provide training, direction and consultation.
6. 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.
7. 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:
8. Bachelor’s degree in a scientific or technical field
9. Experience in the medical device industry with a good understanding of ISO13485 standards, EU MDD and FDA QSR.
10. Career focussed on Quality Management Systems and internal/external audits
11. Experience in corrective and preventive actions, including root cause analysis, documenting findings/actions, and implementing actions
12. An ability to work with cross functional teams across multiple work locations and effectively communicate with senior stakeholders
13. Solid Organisational and Analytical skills - demonstrated ability to trouble-shoot 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 .
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.
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