Senior Quality Engineer Jobs

Position Summary

The Senior Quality Engineer is responsible for managing processes and leading projects to maintain and improve the quality system in accordance with the requirements of, as appropriate, the following standards: IS0 9001, ISO 13485, MDSAP and FDA 21 CFR Part 820/211, EU MDR and other applicable standards. This role leads complaint/CAPA investigations, supplier quality improvement actions, operations production and process control improvements, and product and service quality improvements with the use of statistical techniques and other accepted quality principles. This role plans and executes activities concerned with the development, implementation, maintenance, and continuous improvement of STERIS quality systems.

Duties

1. Serves as the Core Team Member on cross-functional new product/service development teams with focus on the execution of quality plans and design/service transfer.
2. Develops and implements statistically valid sampling plans, designed experiments, capability studies, SPC and trend analysis in support of products and service improvements.
3. Leads process and product corrective actions and problem-solving activities.
4. Reviews the current quality system and recommend / implement improvements as needed.
5. Uses data to perform statistical analysis and recommend process / product changes to improve product and service quality.
6. Leads projects focused on quality system, product quality and service quality improvements.
7. Develops analyses and reports on the performance of the quality system.
8. Leads supplier audits and corrective actions.
9. Leads and supports internal and external quality system audits.
10. Instructs other STERIS employees in quality principles, effective corrective actions, and valid statistical techniques.
11. Collaborates with other departments and facilities within the company on quality related issues.
12. Supervises Quality Engineers and other Quality staff in the execution of their assigned duties and objectives.
13. Maintains product integrity and quality through the evaluation and disposition of nonconforming materials and processes.
14. Perform all other duties as assigned.

Education Degree

Required Experience

1. 6-10 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience.
2. 6-10 years of experience with medical device or other regulated industries preferred.
3. 6-10 years of experience working in an ISO certified environment required.
4. ASQ, QSR or familiarity with QSR/GMP regulations preferred.

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