Philips Senior Quality Engineer 

United Kingdom, England 

677004468

Senior Quality Engineer

Your role:

• Manage and improve the Philips Quality Management System, in accordance with ISO13485 and additional standards.

• Driving CAPA activities from issue identification to closure, effectively project managing CAPA activities, ensuring the quality of CAPA record content and representing CAPAs during audits and CAPA Review Board meetings.

• Facilitate product and process Corrective and Preventive Action (CAPA) investigations and risk assessment from issue identification through implementation of solution and effectiveness monitoring, by working with Functional Owners and Subject Matter Experts.

• To manage and harmonize QMS management processes and ensure the FDA-compliant validation of all QMS Software systems.

• To lead and direct organizational development and process improvement in such a way as to ensure that the Business strategic policy and strategic growth targets are met.

• Identify, collect, analyse & report monthly performance and quality metrics (KPI’s) and other QMS performance data.

• This role offers you chance for hybrid working from our vibrant & exciting new offices in Farnborough, Hampshire.

• From competitive salary and performance bonus to family friendly policies, flexible benefits and access to Philips University, a career at Philips comes with all sorts of wonderful benefits. Be sure to speak to your recruiter about all the benefits on offer.

You’re right for this role if:

• You have worked as a Quality Engineer in the medical device industry with a strong understanding of appropriate global regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485 and ISO 14971.

• You can understand and analyse complex (hardware/software design) problems using root cause analysis tools and techniques that can develop strong investigations.

• You are at your best when you partner with the business, effectively interacting & influencing colleagues across all levels & disciplines.

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.

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