Product 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.
The Quality Engineer is responsible for oversight of system, hardware and software quality and the risk management throughout the product life cycle. The Quality Engineer provides independent oversight of the design input process, design V&V activities, design transfer and product realization, and performance in the field to ensure that all design requirements are effectively met.
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
Ensures that appropriate quality plans are made that include all stages of the life cycle of the product and supports Quality Plan design
Validates key design inputs like: usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs
Provides effective oversight of the execution of the Quality Plan, Inspection Plans, Control Plans, any Risk Management activities, and of all design related activities during the product/system lifecycle
Performs independent technical assessment on product quality performance and post-market product quality analysis
Can Lead quality related problem solving and root cause analysis during design and manufacturing
Uses post-market analytics and statistics to report on product quality performance in the field (provide feedback to manufacturing, suppliers or design teams) and initiates field actions when required
Act as a single point of contact (person assigned to project team) responsible to ensure that software and hardware design meets quality and compliance standards for every milestone
The Quality Engineer also provides analytics to the Business on the efficacy and efficiency of the design and product realization processes
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 plans can be supported and that costs/resources needed to implement the plan are available.
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 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 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 in the range of £45,000
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.
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.
If you forgot your password, you can click the Forgot Password button on the Sign In screen to reset it.
If you have any other questions regarding the recruitment process please refer to our FAQs. In case of technical difficulties with the website, please send an email to firstname.lastname@example.org.
(Note: To ensure fairness and legal compliance in our recruitment processes, only technical issues will be monitored through the above inbox. Please do not submit resumes or applications to this email, as they will not be reviewed. Only applications received through the online application process will be considered.)