Quality and Regulatory Coordinator

Medstrom Ltd; East Midlands; Presencial; GBP 35.000 - 45.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Pension scheme

33 days’ annual leave

Discounts and cashback

Cycle to Work

Training and mentoring

On-site gym

Death in Service

EOT membership

Descripción de la vacante

Medstrom Ltd is seeking a Quality and Regulatory Coordinator to join the Head Office team in Castle Donington. You will help operate and continually improve the QMS, ensuring products and documentation meet quality and regulatory requirements.

You will work with the Director of Quality Assurance & Regulatory Affairs to coordinate change requests, investigations, and audit documentation, while maintaining PMS records and driving continual improvement across the business.

Formación

• Experience in administrative, technical, quality or regulated environments.
• 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 related discipline.

Responsabilidades

• Coordinate and support processing of product, process, documentation and change requests.
• Coordinate customer investigations with internal departments and customers.
• Assist with Root Cause Analysis, action planning and investigations documentation.
• Prepare internal and external audit documentation and maintain audit records.
• Maintain Post Market Surveillance (PMS) records and related documentation.
• Support maintenance and continual improvement of the QMS.
• Collaborate with colleagues across the business.

Conocimientos

Quality management

Regulatory compliance

Documentation

CAPA

Audit support

Communication

Organisation

Educación

Quality/Engineering/Healthcare related qualification

Descripción del empleo

Are you passionate about quality, compliance, and continuous improvement? Would you like to play a key role in ensuring that medical devices and healthcare services meet the highest quality and regulatory standards? If so, we'd love to hear from you.

At Medstrom, we are proud to provide proven, well-evidenced products and services that support our busy customers and help make a real difference to patient outcomes.

Established in 2010, Medstrom has grown substantially while remaining patient-focused and committed to maintaining an open, supportive culture. In 2022, Medstrom became an Employee Ownership Trust (EOT), giving every employee a vested interest in the company and the opportunity to contribute to and share in our 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.

The Benefits

• Starting salary of £35,000 - £45,000 depending on experience
• Contributory pension scheme
• 33 days’ annual leave entitlement (incl. Bank Holidays)
• Discounts and cashback on shopping, supermarkets, and holidays as part of our rewards scheme
• Salary sacrifice schemes, including Cycle to Work
• Structured training, ongoing professional development, and mentoring opportunities
• Free on-site gym for Head Office staff
• Death in Service benefit provided
• Employee Ownership Trust (EOT) membership, with the associated benefits of having a stake in the company

The 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.

About You

To succeed in this role, you'll have:

• 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
• Full UK driving licence, as some travel may be required
• 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 few years and, through our unique ownership model, is continuing to grow, whilst offering great career opportunities for those who are keen to progress.

Webrecruit and Medstrom are equal opportunities employers, 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.