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 abilities
If you feel this is the right role for you, please apply today!