What is a Senior Quality System Engineer doing? Job description and responsibilities

What does a Senior Quality System Engineer do?

We are seeking a Senior Quality System Engineer to join our team and support the development, implementation, and maintenance of our Quality Systems. The Senior Quality System Engineer will ensure the company meets all applicable FDA and International Quality Standards and will be responsible for leading internal and external quality audits. This role requires exceptional communication, organization, and problem-solving skills, as well as a strong attention to detail. The ideal candidate will have a Bachelor’s degree in a related field, at least 5 years of experience in Quality Systems, and a thorough understanding of relevant regulations and standards.

Responsibilities of Senior Quality System Engineer

1. Develop, implement and maintain a quality management system to ensure product and process compliance with customer and regulatory requirements.

2. Monitor and review the performance of the quality system to ensure continuous improvement and compliance.

3. Establish and maintain quality metrics, audit plans, and corrective action plans.

4. Lead internal and external audits and manage corrective and preventive action plans.

5. Investigate customer complaints and non-conformances, and initiate root cause analysis and corrective actions.

6. Coordinate with engineering and production teams to ensure product and process quality.

7. Develop and maintain quality documentation including procedures, work instructions, and specifications.

8. Develop and execute validation plans, protocols and reports.

9. Develop and coordinate process and product inspection plans, and implement quality control systems.

10. Provide technical guidance and leadership to quality assurance and inspection teams.