Senior Quality Engineer
Il y a 2 mois
Job Summary:
We are seeking a highly experienced Senior Quality Engineer to join our client's team in the medical device industry. As a key member of the quality team, you will be responsible for ensuring the highest standards of quality and compliance in the design, development, and manufacturing of medical devices.
Key Responsibilities:
- Interface with R&D, manufacturing, and production teams to ensure seamless collaboration and effective communication.
- Develop and implement process improvements to enhance safety, quality, and compliance.
- Support the quality team in change control processes and ensure timely resolution of non-conformities.
- Lead the qualification of components, including initial sampling and approval of first articles.
- Review and approve test protocols and reports for process validation.
- Oversee the deviation process and non-conformity management.
- Treat internal and supplier reports on non-conforming materials.
- Develop and implement corrective and preventive actions (CAPA) to address quality issues.
Requirements:
- Master's degree in engineering or a related field.
- Minimum 10 years of experience in the medical device industry.
- Knowledge of inspection and testing requirements.
- Understanding of risk management and ISO 14971 principles.
- Comprehension of quality management systems for medical devices (ISO 13485).
- Statistical analysis skills.
About the Company:
Michael Page Santé is a leading recruitment agency specializing in the pharmaceutical, biotechnology, and medical device industries. We provide expert recruitment services to companies seeking top talent in quality assurance, regulatory affairs, and other critical functions.
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