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Design Quality EngineerWe are working with a small but mighty medical device business based near Chesham who are looking to grow their quality team by adding a Design Quality Engineer. As the Design Quality Engineer you will have a strong background in medical device design and development, with a focus on ensuring product quality and regulatory compliance throughout the product lifecycle. You will be integral to supporting the design process, performing risk assessments, and ensuring that products meet both internal and external quality standards.Responsibilities* Support the design and development of medical devices from concept through to production, ensuring compliance with industry standards such as ISO 13485, FDA, and CE regulations.* Conduct design and process risk assessments (FMEA, DFMEA, etc.), and implement corrective/preventive actions where necessary.* Ensure design control processes are followed, including design inputs, outputs, verification, and validation.* Create and maintain design quality documentation, such as risk management files, design dossiers, and validation reports.* Collaborate with cross-functional teams (R&D, regulatory, manufacturing, etc.) to ensure seamless integration of quality standards throughout the product lifecycle.* Conduct audits and assessments to ensure adherence to design controls, quality systems, and regulatory requirements.* Support CAPA (Corrective and Preventive Actions) investigations and root cause analysis for any design-related issues.* Contribute to continuous improvement initiatives within the quality management system.
Required Skills & Qualifications* Degree in Engineering, Quality, Science, Engineering or an equivalent subject * 2+ years' experience in a Design Quality Engineering role within a highly regulated industry.* Knowledge of design control processes.* Good knowledge of ISO14971, ISO13485 and FDA Quality System Regulations* Strong experience with risk management methodologies (e.g., FMEA, DFMEA, etc.).* Proficiency in design documentation, such as risk management files, validation protocols, and reports.* Excellent communication skills, with the ability to work effectively in cross-functional teams.
To be considered for this opportunity you will need to have the right to work in the UK. Unfortunately, we are unable to offer sponsorship for this role.
