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R&D Quality Senior Associate, Medical Devices

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R&D Quality Senior. Associate, Medical Devices 
Kingston upon Hull, East Yorkshire
Competitive Salary & excellent benefits package

The R&D Quality team is being transformed to provide a more aligned partnership model with key stakeholder functions, to provide Quality leadership on key priorities and to guide Quality Culture throughout R&D and the functions involved in product Innovation. Reporting initially to the Medical Devices Quality Director, the role is also ensures compliance requirements to meet with ISO13485:2016, Medical Device Regulation 2017/745, 1SO14971:2019 are understood and embedded into the QMS via a detailed gaps analysis of the as is and supports the planning for integration into Reckitt systems over an agreed period. Through close working with conveying employees and Performance Health team during the integration phase to support their onboarding and to establish a business.  


You’ll succeed because…

•    Ensure Quality has an independent voice and represents the consumer passionately, driving the development teams to ensure actual consumer experience matches the intended consumer experience.
•    Work internally with other key Reckitt Health personnel, to ensure the comprehensive and consistent application of the principles of the RB Risk Management process 
•    Ensures that the Quality Strategy is implemented in support of the Category product strategy and consumer experience 
•    Provides Quality and Quality risk management expertise across the portfolio 
•    Maintains current knowledge of full RB Health product portfolio and oversight of the quality requirements for the product development covering all impacted product classifications with a higher focus on Medicines, Medical Devices and Cosmetics 
•    Supports a QMS such that it is Audit ready at all times by providing expertise with implementation and maintenance of the QMS

You’ll love it because…


…you’ll have the freedom to make a difference. You’ll put your own ideas into practice. The products you get out there will allow people to live healthier lives and have happier homes. And our dynamic, ownership-driven culture will bring the very best out of you, every day.


Skills and experience:

•    Degree qualified or equivalent in a Science, Quality or Engineering discipline
•    Experience of  working in a Healthcare company 
•    Experience of working within a Quality Assurance function or working within an R&D or Regulatory function of a company manufacturing fast moving consumer goods
•    Knowledge and understanding of compliance requirements including as a minimum ISO13485:2016, MDR 2017/745, ISO14971:2019, US Monograph OTC drugs
•    Experience working with or within a QMS developing US Monograph OTC drugs is also advantageous 
•    Knowledge of IEC 62366, the Medical devices usability standard is beneficial
•    Experienced and skilled user of risk management techniques, including FMEA 


In Return Reckitt  offer very competitive salaries with excellent benefits and the chance to progress your career within a truly global organisation.
Reckitt is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other basis protected by appropriate law. All hiring decisions are made based on merit, competence and business need.

Job Segment: Medical, Medical Device, Healthcare

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