Quality Engineer CAPA

Philips ,
Basingstoke, Hampshire
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Job Description

null In 2018, Philips acquired Remote Diagnostic Technologies (RDT), a UK-based leading innovator of advanced solutions for the pre-hospital, military, aviation and maritime market providing monitoring, cardiac therapy and data management. Philips already offers a range of proven monitoring and therapeutic products and solutions to help emergency medical services, hospitals and lay responders accelerate the delivery of care at the scene. This offering includes automated external defibrillators (AEDs), advanced life support monitors, and data management solutions. RDT compliments these with a product range for ambulance and emergency responders, which includes Tempus ALS, a modularized monitor and defibrillator that offers premium functionality in a smaller, lighter and more flexible package. RDT also offers highly robust, yet lightweight monitors equipped with telecommunication capabilities for various emergency responders. Please note, this role will initially be based in our Basingstoke office. We have plans to relocate this office to create a better working space for all of our employees and there is a strong possibility that by the end of 2020, your new work location will be Farnborough, Hampshire As a **Product Quality Engineer y** **o** **u are responsible for** driving CAPA Review Board activities from issue identification to closure, effectively project managing all CAPA activities, ensuring the quality of CAPA record content Representing CAPAs during audits, CAPA Review Board meetings and the main point of contact for CAPA related activities within the business unit. + Facilitate product and process Corrective and Preventive Action (CAPA) investigations, by working with Functional Owners and Subject Matter Experts, from issue identification through implementation of solution and effectiveness monitoring + Monitoring quality data sources including, but are not limited to Adverse Events, Audits (Internal, External, Supplier), Complaints, Corrective Actions (Internal, Supplier), Deviations, Field Safety Actions, Nonconformances (Internal, Supplier), and Servicing on a monthly basis via the CAPA Review Board to provide trending analysis on quality issues and performance metrics in line with KPIs in preparation for Management Review + Perform timely, detailed CAPA engineering tasks like: assessing issue descriptions, reviewing CAPA data sources, assisting with root cause analysis and quality problem solving + Project manage all aspects of CAPA activity which includes gaining the commitment of cross functional resources, scheduling CAPA team meetings, and ensuring CAPA deliverables per project timelines and presenting the data at the CAPA review meeting + Analyze quality monitoring data sources and apply statistical techniques to identify existing and potential causes of non-conformance's + Quality Monitoring spanning the entire Quality Management System (QMS), its elements, and is conducting it through the entire product lifecycle: from design, into operations, supplier controls, acceptance activities, and through post distribution surveillance + Work effectively with all levels of management to ensure CAPA action plans can be supported and that costs/resources needed to implement the plan are available + Help facilitate continuous improvement and learning across all functional **You are a part of a** global company within a business providing remote monitoring and resuscitation solutions for pre-hospital and critical care services that are truly lifesaving **.** A fast growing and innovative Quality & Regulatory team, within an ever-changing environment, located in Basingstoke, UK. The Quality & Regulatory team enables meaningful innovation for our customers by collaborating with and guiding the business to achieve quality and regulatory compliance in a rapidly changing environment. **To succeed in this role, you should have the following skills and experience** + Bachelor's degree in engineering or equivalent technical experience + Demonstarble experience in Quality Engineering and CAPA processes in a medical device or regulated industry + Working knowledge of medical device regulations (21CFR), MDD, MDR, other global laws and regulations and standards including ISO14971, IEC 60601 and related particular standards. + Working knowledge of the new product design and development in a regulated environment; preferably medical device + Working knowledge of the application of risk management; preferably to medical device development + Demonstrated knowledge of tools and techniques required to perform thorough root cause analysis and develop strong investigations. + Able to understand and analyze complex problems, including software and hardware design issues. + Demonstrated ability to partner with the business and effectively interact with and influence employees, and managers on all levels. + Strong Project Management skills, including ability to project manage all CAPA activities. + Ability to analyze dat

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