Operations Quality Engineer
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
You are responsible for primarily managing contract manufactured finished devices/products or services, driving Quality Engineering and Supplier Quality processes related to the development, procurement and continuous improvement of manufacturing materials, components, software, sub-assemblies, and their introduction into Philips supply chain.
Partner with R&D, Operations and Procurement personnel to proactively engineer quality and ensure compliance for contract manufactured finished devices/products or services, 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.
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