Quality and Regulatory Coordinator

We are a manufacturer of specialist hospital beds and manage over 25% of the UK’s acute bed and mattress fleet, working with more than 150 hospitals across the UK and Ireland.

Established in 2010, Medstrom has grown substantially by being patient-focused to become the organisation we are today, whilst maintaining an open culture and ethos. In 2022, Medstrom became an Employee Ownership Trust (EOT), unlike any other company in the industry. This allows each employee to have a vested interest in the company, where we can all contribute to and share in the company’s success.

We are looking for an enthusiastic and experienced Quality and Regulatory Coordinator to join our support team at our Head Office in Castle Donington.

Your Role :

In this role, working closely with The Director of Quality Assurance & Regulatory Affairs, you will support the effective operation and continual improvement of our Quality Management System (QMS), ensuring that products, processes and associated documentation comply with applicable quality and regulatory requirements.

Key responsibilities:

• Coordinate and support the processing of product, process, documentation, and other change requests
• Coordinate customer investigations, gathering relevant information from internal departments and customers
• Assist with Root Cause Analysis, action planning, and documentation of investigations
• Prepare audit documentation (internal and external), maintain audit records, and support the recording of audit findings
• Maintain Post Market Surveillance (PMS) records and associated documentation
• Support the maintenance and continual improvement of the QMS
• Work collaboratively with colleagues across the business

Hours of work: 37.5 per week, Monday – Friday, typically 8am – 4pm, based at Head Office in Castle Donington.

Experience Needed :

To succeed in this role, you’ll have:

Essential
• Experience working within an administrative, technical, quality, or regulated environment
• Excellent organisation and attention to detail
• Strong written and verbal communication skills
• Ability to prioritise and manage multiple tasks
• Good Microsoft Office skills
• Full UK driving licence, as some travel may be required

Desirable
• Knowledge of ISO 13485
• Knowledge of CAPA and non-conformance processes
• Medical device, healthcare, or manufacturing experience
• Relevant qualification in Quality, Science, Engineering, Healthcare, or a related discipline

In addition to the salary and related benefits, you will join a company that has grown extensively within the last 5 years and, through our unique ownership model, is continuing to grow, whilst offering great career opportunities for those who are keen to progress.

Medstrom are an equal opportunities employer, we value diversity and are strongly committed to providing equal employment opportunities for all employees and all applicants for employment. Equal opportunities are the only acceptable way to conduct business and we believe that the more inclusive our environments are, the better our work will be.

Medstrom operates a zero-tolerance policy to any harassment, of any kind, towards our colleagues.

To apply for this role, please click the APPLY HERE button at the top of the page