Quality Manager - SaMD / software as a medical device - Homebased

to £50k + car allowance - Quality/Compliance/Regulatory
Ref: 585 Date Posted: Wednesday 24 Mar 2021
LinkedIn ShareShare

Suitable for:  Quality Manager – Medical Devices / ISO13485 (with SaMD / software as a medical device experience)

Location:  Homebased – with some travel to other sites

Salary: to £50k + car allowance

Our client is a successful software provider within the healthcare sector. They have an immediate requirement for a Quality Manager with experience of SaMd / software as a medical device

Working as part of the Clinical Safety team within this role you will have the responsibility to provide strategy, execution, and management of the company’s ISO13485 quality management system.

Essential Skills:

As Quality Manager the following skills / qualifications are essential:

  • SaMD / software as a medical device experience
  • Minimum of 3 years in a Quality Management position
  • Thorough understanding of ISO 13485 quality system requirements including design controls
  • Demonstrated development and implementation of quality system procedures and policies
  • Ability and desire to implement and oversee continuous process improvement programmes
  • Knowledge of software development and advanced oral, written & computer skills
  • Effective multi-tasking skills, creative problem solver with high attention to detail
  • Certified Quality Engineer (CQE) preferred
  • Bachelor of Science Degree - ideally mechanical or biomedical engineering

The Role

As Quality Manager, you will be required to develop and maintain compliance with all aspects of current MHRA and ISO 13485 quality system requirements and the role will include, but not be limited to, the following:

  • Corporate quality assurance system
  • Product Realisation
  • Complaint handling and product analysis
  • Vigilance and MDD/R reporting
  • Supplier assurance contracts and auditing
  • Manufacturing inspection and maintenance procedures
  • Controlled documentation system
  • Employee quality system training

Full job description is available upon request.

To apply:  Please follow the online application process and upload your CV, in Word format 

Please note: You must be eligible to work in the UK for your application to be considered (sorry, our client is unable to offer sponsorship).  Due to large numbers of applications, unfortunately we cannot provide detailed feedback to everyone, however, if you wish to find out how your application is progressing please call or e-mail the office and someone will help you / get back to you 

At Solo Search we take your data privacy seriously, by applying for this vacancy your data will be processed and likely stored on our secure internal systems. The lawful basis Solo Search use to process your data in regard to this application is legitimate interest and without further consent, your details will be stored for a maximum period of 12 months only. We will only ever use your data to assist you with your job search and this data will not be shared with any third party, including the client, without your explicit consent. Our full Data Privacy Policy can be viewed on our website.