Overview
We are seeking a Quality Engineer with expertise in CFR Part 820 and ISO 13485 standards to join a prestige medical device company based in Hertfordshire on a hybrid basis. The ideal candidate will have experience in the electrical and mechanical fields, with a focus on quality engineering within the life sciences industry.
Responsibilities
Develop and implement quality control procedures and protocols in accordance with CFR Part 820 and ISO 13485 standards
Collaborate with cross-functional teams to ensure product quality and regulatory compliance
Conduct risk assessments and contribute to root cause analysis for non-conformances
Perform process validations and contribute to continuous improvement initiatives
Support quality audits and provide guidance on corrective and preventive actions
Qualifications
Bachelor's degree in Engineering or related field
Knowledge of CFR Part 820 and ISO 13485 standards
Experience in the electrical and mechanical aspects of quality engineering
Previous experience in the life sciences industry is preferred
Strong analytical and problem-solving skills
Excellent communication and teamwork abilitiesIf you feel this is the right role for you, please apply today