Quality Assurance Engineer

Job Description

Quality Assurance Engineer – Medical Device (MDR ISO 13485)

Location: Leeds

Salary: Up to £50,000

Are you a passionate and detail-oriented Quality Assurance professional with an interest in working on a complex medical device? We are seeking a dedicated Quality Assurance Engineer to become the expert in ensuring the highest standards in the development and manufacturing of medical devices. This role offers the opportunity to contribute to the success of an exciting and cutting-edge medical device while receiving training to thrive in the position.

Key Responsibilities:

1. Oversee the implementation and adherence to MDR (Medical Device Regulation) and ISO 13485 in the development of medical devices.
2. Ensure all quality assurance processes align with the latest medical regulation requirements, focusing on MDR compliance.
3. Create and manage standard operating procedures (SOPs), documentation, and reports in line with 13485 standards.
4. Conduct regular audits, inspections, and testing of medical devices to ensure they meet both MDR and ISO 13485 requirements.
5. Support the creation and maintenance of documentation related to regulatory submissions and quality systems for medical devices.
6. Provide expertise on medical regulation and offer guidance for continuous improvement of the medical device lifecycle.

Essential Requirements:

1. Experience in Quality Assurance for medical devices, ideally with knowledge of MDR and ISO 13485.
2. Familiarity with medical regulation and regulatory bodies like FDA.
3. A strong focus on delivering high-quality documentation and ensuring compliance with 13485 standards.
4. Excellent attention to detail, with the ability to manage multiple quality projects simultaneously.
5. Passion for working with medical devices and ensuring their compliance with rigorous MDR standards.

Desirable:

1. Previous experience with FDA approval processes and inspections for medical devices.

This is a fantastic opportunity for someone eager to develop their career within the medical device industry, work in a growing company, and receive the training needed to excel in MDR and ISO 13485 compliance.

If you’re ready to take on the challenge of ensuring the quality and regulatory compliance of complex medical devices, we’d love to hear from you. Apply now and join a dedicated team that values your expertise and is committed to your career development!

This opportunity offers a competitive salary of up to £50,000 and is based onsite in Leeds.

Don’t miss out – your next exciting opportunity in Quality Assurance for medical devices awaits!