Quality and Regulatory Engineer

Job Opening: Quality and Regulatory Engineer

Location: Totton, Southampton

Salary: £37,500 - £40,000 per annum

Employment Type: Permanent, Full Time

Are you looking for a challenging and rewarding role as a Quality and Regulatory Engineer? We have an exciting opportunity based in Totton, Southampton. As a Quality and Regulatory Engineer, you will play a key role in CE marking all class 1 medical devices and ensuring compliance with Medical Devices Regulation (MDR).

Key Responsibilities:

• Ensure compliance with CE marking for class 1 medical devices.
• Manage and update Quality Management System (QMS) processes to meet ISO 9001 and ISO 14001 standards.
• Review product development documentation and determine regulatory requirements.
• Create documentation for regulatory filings of new product development.
• Conduct quality investigations on non-compliances using the 5 Whys methodology.
• Produce written work instructions and implement corrective actions based on investigation findings.
• Collaborate with stakeholders and provide necessary training and support.

Qualifications and Skills:

• Significant experience in Quality and Regulatory roles.
• Knowledge and understanding of ISO 9001, ISO 14001, and relevant regulations.
• Enthusiastic, motivated, and detail-oriented individual.
• Excellent communication and interpersonal skills.

This role offers the opportunity to work with an innovative and forward-thinking company that specializes in providing seating and mobility products and services to both NHS and private clients. If you have the required experience and skills, we invite you to apply for this position.

To express your interest in this role, please submit your updated CV.

Please note that candidates for this role may be required to manage and maintain quality and regulatory processes, and hands-on practical experience is essential.