Quality Manager London, UK/Hybrid 

Odin Vision is a multi-award winning company that provides state of the art AI enabled software applications for endoscopic procedures to aid clinicians in the detection and diagnosis of disease, supporting higher quality care, improved patient outcome and better value for healthcare payers.    

We are looking for an individual to join our growing Quality Team who has experience in managing and maintaining a certified QMS in line with ISO 13485, the UK and EU MDR and FDA CFR Part 11. Candidates should have a good eye for detail, be able to communicate requirements to the company and be a subject matter expert on ISO standards, guidance and regulations related to our QMS.

The role will be based in London, UK with hybrid working

Include a brief description of the position and the structure of the role, is it part time or full time? Will travel be involved? Will it require the management of staff.

We are looking for an individual who has (name skills, core knowledge, experience or qualification). More detail on the below bullet points can be included in this section

What you'll do: 

• Implement and maintain a quality management system to support CE and FDA regulatory approvals for the Company’s software products, this includes, but is not limited to, interacting with auditors, notified bodies, end users, patients and external consultants; 
• Collect and manage data, supporting requirements analysis and documentation, end user testing, verification and validation. 
• Act as the management representative for quality (MRQ) with the defined authority and responsibility to ensure that the QMS is established, implemented and maintained in compliance with the regulatory standards. 
• Log any non-conformities raised on the system 
• Work with the line managers to ensure all employees are trained and competent
• Maintain up to date register of labelling 
• Maintain an electronic QMS in an organized and searchable way
• Collect and present data for Management Review Meetings 
• Authorize and issue documents 
• With the DPO, ensure our data security and GDPR procedures reflect current regulations 
• Define and manage the risk management processes and participate in risk management activities 

Qualifications

• Internal Auditors Qualification

Experience

• 5 years of professional experience with ISO 13485
• Experience with EU MDR transition 

Desirable for the role

• Experience with Software as a Medical Device
• Knowledge of the regulatory pathways for Medical Devices 

At Odin Vision we believe that diversity is an important contributor to our success and long-term company goals. Diversity in our teams can contribute to innovations and creativity and increase our ability to cope with change. Odin Vision is committed to encouraging equality, diversity and inclusion among our workforce, and eliminating unlawful discrimination. The aim is for our workforce to be truly representative of all sections of society and our customers, and for each employee to feel respected and able to give their best.

 
 Quality Manager London, UK/Hybrid 

Find out more:  

Follow Odin Vision on LinkedIn 

https://www.linkedin.com/company/14067058/ 

https://odin-vision.com/