Quality System Engineer - Medical Industry (Hybrid working)

Outline:
This is fantastic opportunity for someone who has Quality System Engineering experience from within the medical or pharmaceutical industry and wants to further their career with an award-winning international business!

The Company:

• An international company that offers fantastic training and development, with genuine career progression opportunities.
  
  
• They’re a highly regarded by both customers and employees, known as a great place to work.
  
  
• The business is respected across the globe and have many award-winning products.
  
  
• An established company with sustained growth.
  
  The role overview:
  
  
• This Quality System Engineer role offers hybrid working, 3 days in the office with the other 2 flexible to WFH etc, with the head office based near Maidenhead.
  
  
• As a Quality System Engineer you will support the Quality Manager in various ways.
  
  
• Your duties will include the management, development, implementation, and continual improvement of an efficient and effective Quality Management System (QMS).
  
  
• In this role you will ensure all activities comply with the company QMS and applicable industry / regulatory standards
  
  
• These include ISO 13485, UK MDR and EU MDR/MDD requirements, which you will ensure you comply with at all times.
  
  
• It’s vital that you identify and implement opportunities for improvement within the organisation to support business and quality goals and objectives within the business.
  
  
• You will plan and conduct internal audits, using them as a proactive tool for improvement as well as compliance.
  
  
• Parts of the role will also include the processing and logging of Document Change Requests, acting as the Change Management QA Representative, conducting trend analyse, along with other suitable duties.
  
  Package:
  
  
• Basic starting salary: Up to £45k
  
  
• 25 days annual leave plus bank holidays
  
  
• Generous Pension Scheme
  
  
• Private medical insurance
  
  
• Life Assurance
  
  
• Wellness program
  
  
• Reward schemes
  
  The ideal person:
  
  
• You will need to be educated to degree level in Life Science, Engineering, or an equivalent discipline, and have a minimum 2 years relevant experience within the medical device industry.
  
  
• It is vital that you have a good working knowledge of EN ISO 13485
  
  
• You will need experience of auditing and assessing to ISO standards and regulations within the medical industry
  
  
• A working knowledge of Medical Device Directive / Medical Device Regulations is highly desirable.
  
  
• You must have excellent communication skills, both verbally and written, along with being highly proficient in spreadsheets and word processor applications such as MS Word and Excel.
  
  
• You must live a suitable commutable distance from the Head Office near Maidenhead or be willing to re-locate before starting the role (no relocation package available)
  
  
• Right to work in the UK is essential
  
  If the above is of interest to you and you fit with the Ideal Person section, then please get in touch with us and we can discuss the role in more detail