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some of the <a href="https://www.careers.philips.com/global/en/faq" target="_blank">frequently asked questions </a>. </p><p></p><p><strong>Equal opportu
lso learn about our <a href="https://www.careers.philips.com/global/en/recruitmentprocess" target="_blank">recruitment process </a>, or find answers to
ad stories from our <a href="https://www.careers.philips.com/global/en/blog" target="_blank">employee blog </a>. Once there,you can
ways. Learn more by <a href="https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.youtube.com%2Fwatch%3Fv%3DSjsIRScenFg%26feature%3Dyoutu.be&data=02%7C01%7C%7C2e6ce27a447d492df73708d75d39b5e2%7C1a407a2d76754d178692b3ac285306e4%7C0%7C0%7C637080374748362775&sdata=TafLfASqXFFV8BfOyCLajnNAUVmElZ5pjraYLrl%2FOjc%3D&reserved=0" target="_blank">watching this video </a>. </p><p></p><p>To find out mor
al level, visit the <a href="https://www.careers.philips.com/professional/global/en/workingatphilips" target="_blank">Working at Philips page </a> on our career websi
olutions across the <a href="https://www.philips.com/b-dam/corporate/corporateblog/2016/Philips_Chronic_Disease_5.jpg" target="_blank">health continuum </a>. Our people experie

Job Information

Philips Operations Quality Engineer in Basingstoke, United Kingdom

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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.

You are responsible for driving Quality Engineering, Purchasing Controls and Supplier Quality processes related to the development, procurement and continuous improvement of manufacturing materials, components, software, sub-assemblies, contract manufactured finished devices/products or services, and their introduction into Philips supply chain.

  • Partner with R&D, Operations and Procurement personnel to proactively engineer quality and ensure compliance for raw materials, components, finished Service products etc., from suppliers

  • Develop and support regulatory compliance gaps at suppliers, including supplier quality system, supplier quality agreements and process development activities

  • Manage additions/deletions/changes to the status of suppliers on the Approved Supplier List, including supplier master file records

  • Ensure raw materials/components/products at supplier(s) are released from supplier(s) to Philips according to the agreed specification and quality requirements

  • Perform 3rd party product compatibility risk assessments in partnership with R&D and Market Procurement

  • Drive quality and compliance development and/or improvement at suppliers when needed; Philips face to supplier(s) on lean improvements

  • Establish the Qualification of Parts, identification of supplier processes for CtQ's, supplier process control plans to ensure part quality; ensuring that the supplied part meets specifications, and the control limits/tolerances for CtQ parameters are met

  • Ensure raw material and component specs and drawings are translated to supplier quality requirements, qualify suppliers, assess metrics of whether supplier products meet quality specifications, verify quality inspection and audit suppliers critical to quality processes

  • Ensure that validations are completed where specified, and control plans exist to ensure the sustained quality and compliance of supplied raw materials and components

  • Ensure correction and prevention activities of suppliers are timely and effective, and their escalation to SCARs where needed

  • Ensure supplier audit schedules are developed and maintain including the undertaking of supplier audits where necessary

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

  • Demonstrable 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 statistical techniques required to perform thorough root cause analysis and develop strong investigations.

  • Able to understand and analyze complex problems, which may 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 activities, ability to prioritize and time manage effectively

  • Excellent written and verbal communication skills

  • Must be able to travel locally and internationally / full drivers license

  • Lead auditor training to ISO13485:2016 (beneficial)

  • Able to read, understand/ interpret Engineering drawings and ability to use basic measurement hand tools, e.g. vernier gauges, height gauges, torque drivers

In return, we welcome you to a challenging, innovative environment with great opportunities for you to explore. Our benefits are very competitive and designed around your preferences:

  • A competitive basic salary

  • 25 Days of leave and the possibility to purchase up to 5 extra days off annually

  • A variable bonus based on both Philips results and personal performance

  • Extensive set of tools to drive your career, free training and coaching

  • Solid company pension scheme

  • Opportunity to buy Philips products with discount

  • Healthy work-life balance

Why should you join Philips?

Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video .

To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog . Once there,you can also learn about our recruitment process , or find answers to some of the frequently asked questions .

Equal opportunities

Philips are an equal opportunities employer and welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.

Should you require any reasonable adjustments to enable your participation in the interview process, please advise us of this in your application.

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