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Quality Assurance and Regulatory Affairs Manager

Contract type
Permanent
Working Pattern
Full time
Location based
Thame
Hours per week
40
Dates that interviews will take place
Interviews will be held via MS Teams
Salary
£45,000 - £60,000 plus benefits
Summary of vacancy

Do you have a Quality Assurance background working with ISO13485 ?

When you join SUEZ WPS, you get more than a brand-new role. Your work will help us deliver innovative and environmentally responsible solutions for water and waste management.

You will get a chance to help us preserve and restore our planet’s natural capital for future generations. It’s a career that’s not only exciting, but full of opportunities as well as professional and personal fulfilment.

Please be aware this role is based in Thame with hybrid working.

About the role

About the role

  • We are seeking a Regulatory Affairs & Quality Assurance Manager to support our existing range of water purification medical devices for haemodialysis market and non-medical laboratory water purification products.
  • The RAQA Manager is directly responsible for execution of the facility's quality management system.
  • The role will involve taking ownership and management of the quality management system as a whole and ensuring compliance with ISO13485, EU and UK Medical Devices Regulations and other relevant international standards.
  • The role will involve maintaining, managing and monitoring the company’s quality management systems, supporting the technical development of the devices and ensuring the devices meet the requirements of national and international standards and regulations. 

What will I be doing?

  • Definition and review of company quality procedures.
  • Ensure compliance with company quality procedures.
  • Generation and review of both project and technical documentation.
  • Compilation and submission of design files.
  • Liaising with notified bodies and relevant authorities.
  • Management of contractors and suppliers.
  • Supporting and performing verification and validation of devices.
  • This is a hands-on role that offers a unique opportunity to be an integral part of a Global water purification group of companies. This will allow any candidate to be involved in many aspects across the business and therefore significantly broaden their experience and allow them to grow with the company. 

What are the requirements?

Essential Skills and Experience

  • 2 – 5 years of quality management experience, preferably in relation to Class IIb medical devices.
  • Broad knowledge of engineering principles.
  • Risk management processes, preferably in accordance with ISO 14971.
  • Quality management, preferably in accordance with ISO 13485:2016.

Experiences

  • Minimum 2 years in a RA/Quality leadership role required

Skills

  • Experience with quality system elements including but not limited to CAPA, Complaints, process monitoring, change control, document control, management review, supplier management and continuous improvement.
  • Expected to host Regulatory, Notified Body and Customer audits and manage any resulting remediation plans.
  • Working experience of medical device regulations and industry standards globally specifically, ISO 13485:2016, ISO 14971 and euMDR 2017/745, UKCA marking and  UK Medical Device Regulations 2002
  • Strong analytical and technical skills that include data collection, analysis and required report generation
  • Strong communication skills and ability to work both, independently and cross-functionally with Production, R&D, Marketing and other applicable functions within the business
  • Demonstrated ability to think outside the box and make recommendations for improvement
  • Good presentation and writing skills (summary reports, evaluations, etc.)
  • Fluent in English
  • Experience writing and updating and compiling technical files with experience of UKCA & eu (MDR) Marking
  • Previous medical device experience is strongly preferred but not essential.
  • Necessity to be able to interpret regulatory requirements and standards
  • Our ideal candidate will be experienced in the Quality/Regulatory arena and Auditor Qualified to ISO13485 (Medical Devices).
  • Proven experience of Regulatory management as well as commercial experience as a Regulatory Manager
  • Prior experience working within the Medical industry ideally with experience of class IIb Medical Devices
  • Experience keeping abreast with the latest industry standards
  • Knowledge of water purification process would be an advantage (optional). Training would be provided.

Who we are

At SUEZ WPS the efficient and sustainable management of resources around the UK is at the heart of everything we do. Respect – acting ethically and with integrity – is one of our core values. We’re passionate about the environment and believe in protecting our world. With true team spirit, we can give our customers a standard of service that goes above and beyond and ensure that our local communities have access to essential water and waste services.

We thank our people for all they do with development opportunities, wide-ranging benefits and rewards that reflect their hard work. In a friendly, supportive environment, you’ll be inspired to grow and play your part in creating a better future for all. 

*** NO AGENCIES PLEASE **

Closing Date
26/05/2022
Once we have sufficient applicants we withhold the right to close job vacancies early.